FDA event 94989 · Recall Observatory

device · product 1 of 36

Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2645-2024

Recall number: Z-2645-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 20,034 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065771540; UDI-DI: 00380657715404; Lot numbers: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, 16DDRU

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 2 of 36

Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

Z-2646-2024

Recall number: Z-2646-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 3,721 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065751658; UDI-DI: 00380657516582; Lot Numbers: 16C4MR, 16K84T, 16FXTD.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 3 of 36

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A

Z-2647-2024

Recall number: Z-2647-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 8,701 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065830077; UDI-DI: 380658300777; Lot numbers: 16A6HT, 16A6HU, 16A6HV, 16FX1Y, 16FX20, 16FE93, 16HE6Y, 16HE70, 16HYEN, 16HYEP.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 4 of 36

Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Z-2648-2024

Recall number: Z-2648-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 384,851 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

UDI-DIs: H5301ALCON1CPAK10 and H5302ALCON2CPAK20; Model Catalog numbers: 0210-71, 0515-65, 0613-84, 0775-69, 0835-60, 0852-75, 0884-77, 0900-28, 0972-31, 0995-82, 10027-12, 10066-19, 10068-19, 10214-20, 10214-21, 10275-17, 10308-11, 10342-17, 10477-21, 10568-13, 10604-09, 10731-20, 10772-35, 10782-30, 10825-17, 10931-13, 11066-08, 11220-25, 11367-23, 11413-14, 11414-07, 11426-24, 11497-12, 11732-16, 1192-67, 11952-15, 11958-08, 11994-15, 12005-09, 12262-06, 12329-16, 12346-08, 12359-14, 12364-13, 12376-03, 12382-10, 1239-67, 12417-11, 1249-62, 12498-07, 12518-11, 12532-05, 12698-09, 12699-12, 12918-12, 12918-13, 12942-18, 1303-69, 13204-19, 13214-21, 13335-11, 13569-13, 13578-17, 13592-15, 13614-16, 13644-08, 13657-10, 13732-19, 13870-09, 13894-16, 13944-12, 13955-09, 13982-13, 14129-09, 14174-15, 14226-12, 14302-07, 14362-18, 14363-14, 14385-05, 14387-05, 14429-09, 14442-16, 14477-12, 14611-15, 14688-15, 14719-09, 14853-13, 14864-11, 15061-09, 15133-16, 15190-16, 15194-09, 15220-10, 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C29067-02, C29073-05, C29074-04, C29075-01, C29076-01, C29080-03, C29084-01, C29085-03, C29088-01, C29089-04, C29093-03, C29097-02, C29098-02, C29114-03, C29116-02, C29117-02, C29124-02, C29126-01, C29130-02, C29134-02, C29136-02, C29143-02, C29152-01, C29153-02, C29160-04, C29161-03, C29162-02, C29166-01, C29169-02, C29170-02, C29171-01, C29175-01, C29176-01, C29184-02, C29187-01, C29189-02, C29190-01, C29192-03, C29197-01, C29205-01, C29206-01, C29206-02, C29208-01, C29209-02, C29213-01, C29217-02, C29223-02, C29224-03, C29225-01, C29225-02, C29232-01, C29235-01, C29242-01, C29251-01, C29254-01, C29260-01, C29261-01, C29262-01, C29262-02, C29265-01, C29270-01, C29273-01, C29275-01, C29275-02, C29276-01, C29290-01, C29295-01, C29304-01, C29305-01, C29313-01, C29315-01, C29323-02, C29331-02, C29332-02, C29333-01, C29334-01, C29339-01, C29342-01, C29346-01, C29347-01, C29349-01, C29352-02, C29355-02, C29368-01, C29375-03, C29381-01, C29382-01, C29383-01, C29384-01, C29387-01, C29398-01, C29411-02, C29433-01, Q29139-01, Q29159-01, Q29188-01, Q29195-01, Q29237-01, Q29258-01, QNS29155-01, QNS29189-01, QNS29216-01, QNS29232-01, QNS29236-01, QNS29247-01; Lot numbers: 165FKV, 165DRJ, 165YN0, 165Y8W, 165YA5, 165YPJ, 1667A5, 166798, 1668VE, 166EDM, 166EDF, 166C7D, 166H41, 166MY2, 166N03, 166N0Y, 166PNU, 166PM7, 166PMR, 166PNW, 166PMU, 166PPA, 166PP1, 166PPC, 166PN0, 166PNM, 166V8P, 166V7J, 166V6W, 166VR2, 166V6M, 166YH3, 16734T, 16719J, 166YKD, 166YHM, 16716R, 1673RW, 16765V, 1677HD, 1674D0, 1673PM, 1673U5, 1677CM, 1673P9, 1673NX, 1673PD, 1673R8, 1673RC, 1673PH, 16744C, 16745K, 1677DN, 167469, 1674CY, 16775Y, 167738, 1677E8, 167876, 167849, 167874, 16787W, 167EF7, 167E1N, 167DYT, 167ART, 167ARD, 167AC2, 167F4X, 167HN8, 167JX7, 167JVX, 167JVC, 167JVD, 167JWA, 167JV3, 167JVM, 167LND, 167MN9, 167MNL, 167R0M, 167R1W, 167MNH, 167UF5, 167UHC, 167UF7, 167TAT, 167UM6, 167VJK, 167VJ9, 167TJ4, 167THF, 167TF5, 167TF7, 167TA0, 167UMA, 167V1N, 167TFR, 167TKU, 167UKX, 167UFX, 167UFP, 167TAX, 167UH4, 167TC1, 167UK1, 167V2F, 167XYL, 167YFJ, 167XAF, 167XAL, 167YFE, 167YFP, 167XAM, 167W1H, 167W18, 167W22, 167VY6, 167VXC, 167W5E, 167W1W, 167VYK, 167VXX, 167XCN, 167VXR, 168077, 1681F7, 1681HA, 167YW8, 168099, 16803H, 167YY8, 1681HT, 167YX6, 167YY9, 168282, 16828U, 16828T, 1682PP, 1682NP, 1682R2, 1682R0, 1682T9, 1682TD, 1682TT, 1682NF, 1682P7, 1683W0, 1683W1, 1683W2, 1686E9, 168571, 16864J, 16858H, 1686EN, 16855L, 16856U, 16858C, 16863P, 16858J, 168555, 1687ND, 168993, 1687JV, 1687K2, 1687XT, 1688MR, 1687UW, 1688N9, 1689T5, 1689T0, 1689R0, 168AWR, 1689KV, 1689LM, 1689KD, 1689JT, 1689JV, 1689TE, 1689RM, 1689TL, 1689P3, 168CU8, 168CUP, 168E53, 168E4U, 168CU2, 168CUR, 168CWP, 168CW7, 168E4C, 168E4H, 168E4J, 168E60, 168E5T, 168DEL, 168DEM, 168E5C, 168D9Y, 168E5K, 168EJ0, 168EJP, 168EHR, 168EJV, 168EK8, 168EJE, 168EKH, 168F4M, 168F64, 168F51, 168F61, 168F6U, 168F54, 168F5K, 168F5E, 168J08, 168J15, 168J0W, 168J13, 168J1U, 168J0U, 168JDN, 168JCW, 168LL4, 168LLM, 168LDX, 168KC9, 168K4X, 168K5Y, 168LD1, 168LCJ, 168LEW, 168LCK, 168LAX, 168LD9, 168LD4, 168LDD, 168LCM, 168LK6, 168KJ7, 168LD6, 168LH5, 168K52, 168KE5, 168KAU, 168LF0, 168KDK, 168KAP, 168LMD, 168NH1, 168NEU, 168NPN, 168NHM, 168NVV, 168M8N, 168NTN, 168M5W, 168M91, 168M3A, 168M3K, 168M5M, 168M79, 168M8R, 168PXC, 168UA6, 168U1N, 168U2W, 168U2Y, 168R7K, 168R85, 168UXF, 168U1T, 168U2N, 168VJT, 168VKM, 168VJR, 168VKP, 168VK9, 168VK5, 168VPH, 168VTR, 168VPY, 168VKF, 168VKW, 168VL9, 168VLA, 168VL2, 168VJD, 168VLC, 168VKX, 168VK0, 168VJF, 168VKY, 168VJU, 168VLD, 168VJV, 168VKH, 168VJJ, 168VKJ, 168WV8, 168WV9, 168X5M, 168X5F, 168XEH, 16902C, 16900J, 16902F, 169002, 16902A, 16916C, 1692PM, 169155, 16918J, 1692PL, 16915L, 1691M1, 1692CR, 1692CY, 1692N7, 1692AT, 16918W, 1691A5, 1692C1, 1692MC, 1694R1, 16950L, 1693RA, 1693LC, 1693LK, 1694TA, 1693UR, 1694P6, 16951Y, 1697JF, 1697HA, 1696DT, 1697JH, 16963V, 1696AM, 1697FT, 1697H8, 169601, 1697J9, 1697JC, 1696A9, 1697FR, 1695YW, 1697HN, 169604, 1698A1, 1698K9, 1699K5, 1698A0, 1698KX, 1698KL, 16988K, 169877, 1698L2, 169A10, 169A24, 169A2L, 169ADT, 169AE6, 169AH4, 169AF0, 169E0W, 169D23, 169D22, 169D2L, 169D27, 169CK1, 169CH9, 169CHU, 169CHT, 169F7X, 169FE9, 169E8X, 169E90, 169F79, 169F7A, 169E2X, 169F6C, 169E63, 169E3C, 169F6F, 169F6H, 169F7C, 169E6V, 169J3W, 169J34, 169J3X, 169J54, 169J5X, 169J6M, 169J6C, 169K3V, 169K60, 169J48, 169K45, 169J5T, 169J8E, 169K4V, 169KTM, 169M5D, 169M6A, 169M6C, 169M74, 169M1R, 169NL1, 169NJ8, 169M4U, 169NJ3, 169NJ6, 169M1A, 169NJ4, 169R8F, 169NLD, 169RPR, 169R89, 169RXR, 169RY6, 169TX0, 169TWT, 169T1C, 169T10, 169TXF, 169T4H, 169T3C, 169RXL, 169RYU, 169TW8, 169TW0, 169RYV, 169TVX, 169T3P, 169TWN, 169T22, 169T01, 169T00, 169T14, 169U86, 169U87, 169U8D, 169U8K, 169U8T, 169UML, 169UN6, 169UNL, 169UM8, 169UNH, 169UPD, 169UU0, 169URY, 169UTF, 169ULK, 169UT7, 169UMY, 169UTT, 169W85, 169VJX, 169V82, 169VJU, 169VJP, 169W4J, 169VK6, 169WDD, 169WVL, 169VHC, 169VHJ, 169VH8, 169VH9, 169VHM, 169VHV, 169Y4W, 169Y65, 169Y6M, 16A135, 169Y54, 16A0P5, 169Y68, 169Y49, 16A0LY, 169Y86, 16A0MU, 16A0L9, 16A0LM, 16A0KY, 169Y8P, 169Y8D, 16A30F, 16A245, 16A249, 16A24F, 16A37T, 16A30J, 16A37R, 16A24R, 16A24M, 16A326, 16A23M, 16A23H, 16A30L, 16A32J, 16A31M, 16A2JA, 16A2FJ, 16A31E, 16A3EY, 16A37N, 16A4C0, 16A4VJ, 16A79X, 16A6M7, 16A5ED, 16A68D, 16A6MT, 16A5EA, 16A55J, 16A4UM, 16A4U7, 16A55V, 16A4VX, 16A7AU, 16A55N, 16A552, 16A6L6, 16A4UV, 16A5E9, 16A4MN, 16A7A1, 16A78M, 16A7AC, 16A4RX, 16A55W, 16A7A8, 16A695, 16A78P, 16A5EN, 16A56F, 16A4MJ, 16A54X, 16A55D, 16A68W, 16A55K, 16A7A0, 16A7Y9, 16A9JL, 16A7YM, 16A88E, 16A80E, 16A80X, 16A9JC, 16A84X, 16A80N, 16A812, 16A9LP, 16A9JX, 16A8Y5, 16A885, 16A87T, 16A858, 16A7TT, 16A86W, 16AAL1, 16AALP, 16AAMP, 16AAM2, 16ACKC, 16ACHM, 16ACHE, 16ACFD, 16ACFE, 16ACHF, 16ACFF, 16ACJ6, 16ACFH, 16ACJ8, 16ACFL, 16ACHT, 16ACR2, 16ACJ0, 16ACH7, 16ACJL, 16AE8X, 16AEKK, 16AEL7, 16AE8A, 16AEK3, 16AEK2, 16AE8C, 16AEK6, 16AE8L, 16AE7R, 16AE8N, 16AHT7, 16AJ1U, 16AH1C, 16AH12, 16AJCE, 16AH0H, 16AH1E, 16AJ0N, 16AJ25, 16AHPV, 16AJ1N, 16AHN8, 16AH0D, 16AFYT, 16AHNF, 16AJ0W, 16AFYU, 16AFJ1, 16AFJ6, 16AHPX, 16AJ1A, 16AHUE, 16AH1J, 16ALR4, 16AKL3, 16AKCT, 16ALP0, 16AKDL, 16AKDA, 16AKCC, 16AKED, 16AKCD, 16AKLE, 16AKC8, 16AKDP, 16AKDW, 16AKDH, 16AKDY, 16AKFM, 16ALRM, 16ALPU, 16ALNE, 16ALRN, 16AKLC, 16ALPK, 16ANWL, 16ANWM, 16ARH7, 16ARF3, 16ARHW, 16ANV0, 16ARX1, 16ANV5, 16ANVY, 16ANV8, 16ARRK, 16ARPV, 16ARN4, 16ARW2, 16ARR5, 16ARDF, 16ARPN, 16ARNA, 16ARWY, 16ARPP, 16ATNW, 16ATR1, 16ATP0, 16AUVL, 16AUVX, 16ATUV, 16AUV1, 16AUV5, 16ATT5, 16ATRW, 16ATT7, 16ATRR, 16ATPT, 16ATX2, 16AURF, 16AURH, 16AUUF, 16ATWX, 16AVVX, 16AVX6, 16AVVY, 16AVX2, 16AVXT, 16AVWE, 16AVWF, 16AVW3, 16AVXJ, 16AVWV, 16AW9H, 16AW90, 16AW98, 16AW82, 16AW7M, 16AW8W, 16AWVA, 16AWUT, 16AW8V, 16AWV9, 16AYLR, 16AY42, 16AYK3, 16AYJM, 16AYL8, 16AYJ8, 16AYKV, 16AYLJ, 16C24A, 16C0K7, 16C0K1, 16C0TF, 16C25V, 16C0KL, 16C26T, 16C0T4, 16C0MN, 16C0TJ, 16C0HU, 16C24C, 16C0LW, 16C0HN, 16C0HK, 16C0J5, 16C0TV, 16C0J0, 16C23U, 16C247, 16C242, 16C244, 16C25D, 16C288, 16C0WE, 16C0MM, 16C0U3, 16C0RR, 16C1HH, 16C5WK, 16C3TX, 16C3X0, 16C49K, 16C5WE, 16C475, 16C48W, 16C3UD, 16C5FD, 16C5H6, 16C3U2, 16C5JF, 16C3RF, 16C5WP, 16C3U5, 16C3TC, 16C5KX, 16C5KP, 16C5L7, 16C3X1, 16C3WJ, 16C3U9, 16C3V3, 16C5J6, 16C5JU, 16C5J8, 16C3WW, 16C93K, 16C6X4, 16C9AY, 16C7CU, 16C6TT, 16C6TP, 16C6V3, 16C95J, 16C7DH, 16CA0C, 16C93A, 16CA0N, 16C7D7, 16C94U, 16C9C2, 16C962, 16C94T, 16C95N, 16CA9H, 16CAAD, 16CAE2, 16CAEC, 16CCJY, 16CCJC, 16CCHM, 16CCK8, 16CCJ1, 16CCK9, 16CCKC, 16CD7N, 16CD7V, 16CD7U, 16CDUA, 16CD6N, 16CD8H, 16CD6K, 16CFJA, 16CEUT, 16CF1W, 16CET7, 16CF2Y, 16CETD, 16CEV9, 16CETP, 16CEUK, 16CEUL, 16CFW5, 16CFUY, 16CHRU, 16CHUC, 16CFW3, 16CHTL, 16CHTU, 16CFWF, 16CK0T, 16CJYE, 16CK0W, 16CK11, 16CK19, 16CKAR, 16CK8F, 16CK8D, 16CK07, 16CK1N, 16CK1H, 16CK1U, 16CK1V, 16CNCH, 16CND9, 16CNAV, 16CNAX, 16CNEH, 16CNC1, 16CNF0, 16CNC4, 16CND7, 16CNEL, 16CR07, 16CR30, 16CR04, 16CR26, 16CR0M, 16CR0J, 16CR00, 16CR3M, 16CRLU, 16CR2N, 16CR13, 16CR2M, 16CPYR, 16CR09, 16CV40, 16CUV7, 16CUUD, 16CTW2, 16CUWH, 16CTVL, 16CTVX, 16CTWT, 16CTVC, 16CUWD, 16CV4A, 16CU5K, 16CUWA, 16CTVY, 16CU4W, 16CU52, 16CU5A, 16CUWK, 16CUUT, 16CUV0, 16CW91, 16CX6T, 16CY49, 16CXLR, 16CW8D, 16CW9D, 16CX81, 16CXFJ, 16CW93, 16CW8W, 16CX8M, 16CWL1, 16CWL2, 16CXKP, 16CX8N, 16CX7D, 16CX7U, 16CXHJ, 16CYXA, 16CYVY, 16D16H, 16D16N, 16D16P, 16D15C, 16CYTH, 16CYX7, 16D1M9, 16CYX8, 16CYX5, 16D15M, 16D1MW, 16D15U, 16D15L, 16D15X, 16D1M3, 16D1LK, 16D1LD, 16D20R, 16D20K, 16D1N2, 16D20N, 16CYXH, 16D345, 16D318, 16D320, 16D2EA, 16D2A1, 16D2AM, 16D319, 16D2VU, 16D2EL, 16D2C4, 16D32U, 16D31F, 16D32A, 16D29H, 16D2YC, 16D2YE, 16D333, 16D334, 16D32W, 16D2A9, 16D30H, 16D2YH, 16D29M, 16D2CC, 16D29V, 16D325, 16D2AW, 16D3EL, 16D3F7, 16D3EM, 16D3H3, 16D3EV, 16D3EW, 16D3EJ, 16D3ER, 16D3EX, 16D3FD, 16D3VR, 16D3XP, 16D3X8, 16D3WH, 16D3V3, 16D3WJ, 16D3UX, 16D3WY, 16D3VA, 16D3XA, 16D3XJ, 16D3XL, 16D3V8, 16D3WX, 16D55C, 16D55T, 16D55D, 16D55R, 16D564, 16D57K, 16D57H, 16D546, 16D54E, 16D54D, 16D50Y, 16D6VW, 16D88F, 16D6VR, 16D6VY, 16D7U7, 16D6VJ, 16D88P, 16D7P4, 16D88Y, 16D88X, 16D892, 16D7PJ, 16D7NN, 16D7VP, 16D88W, 16D894, 16D7X9, 16D7PU, 16D6WJ, 16D6V1, 16D6V8, 16D8AV, 16D88C, 16D6WF, 16D7RJ, 16D7PD, 16D7PV, 16D6VP, 16D7NR, 16D7P7, 16D7RN, 16D88N, 16D8A8, 16DAC3, 16DACP, 16D8WJ, 16DAD9, 16D9KU, 16D8W8, 16D9L8, 16DACN, 16D9L1, 16D94K, 16D9JX, 16D9LF, 16D9JN, 16D8V2, 16D93X, 16D8WW, 16D9K2, 16D9LL, 16D9U8, 16DAD8, 16DACD, 16D8WD, 16D9K9, 16D94A, 16DAD2, 16D94F, 16D9K5, 16D9TH, 16DAC2, 16DAD3, 16DCFR, 16DCCU, 16DCFU, 16DC98, 16DCCP, 16DCH1, 16DC8X, 16DCH2, 16DCLA, 16DDM0, 16DDLN, 16DCEH, 16DF36, 16DFLP, 16DETX, 16DEWA, 16DEUE, 16DEPW, 16DFJ8, 16DFFA, 16DEUR, 16DEU0, 16DEWF, 16DETY, 16DETA, 16DETD, 16DETC, 16DEWJ, 16DKEA, 16DKDP, 16DL1R, 16DN6A, 16DN6U, 16DN5V, 16DNRM, 16DNRK, 16DNKP, 16DNN7, 16DNMJ, 16DNPT, 16DNKA, 16DNKR, 16DR4U, 16DR4Y, 16DT5C, 16DR3K, 16DTCD, 16DT59, 16DPPP, 16DR3W, 16DTC9, 16DVV8, 16DVFF, 16DVFE, 16DVJC, 16DVF4, 16DVJ4, 16DU5A, 16DVL1, 16DVVR, 16DVF9, 16DU5N, 16DU4P, 16DU4C, 16DU60, 16DVKH, 16DVFA, 16DVJK, 16DVK9, 16DVKX, 16DXJU, 16DXK0, 16DWXE, 16DXM5, 16DWY1, 16DX01, 16DWYM, 16DWYF, 16DWY6, 16DX07, 16DWY0, 16DXM2, 16DW9D, 16DY0C, 16DXYX, 16E002, 16DYJ9, 16DY0P, 16DXYC, 16E0HV, 16E0J4, 16E0H1, 16E0XL, 16E0Y1, 16E0XC, 16E2T0, 16E1HV, 16E1JH, 16E1J9, 16E2T1, 16E2T2, 16E2TH, 16E2TY, 16E1JY, 16E1H4, 16E2VJ, 16E2U1, 16E2VL, 16E2A2, 16E3UL, 16E3KA, 16ECTN, 16EDH6, 16EE2Y, 16EEAJ, 16EEAV, 16EDJM, 16EE16, 16ECTM, 16EEA4, 16EEA5, 16EE4P, 16EDJE, 16EDH9, 16EDJ0, 16EDJK, 16EDFX, 16EDJC, 16EDK9, 16EDH8, 16EEAF, 16EDHH, 16ECV9, 16EF2R, 16EF61, 16EF2J, 16EF1U, 16EF1V, 16EF32, 16EF1X, 16EF1Y, 16EF2U, 16EF3C, 16EF2W, 16EF3T, 16EH0U, 16EJC0, 16EF3U, 16EFA3, 16EF66, 16EJ8K, 16EH28, 16EJ8X, 16EJ24, 16EF9X, 16EF9T, 16EF9V, 16EJ8A, 16EJ88, 16EJ87, 16EK3D, 16ELV1, 16EK5J, 16EK69, 16EK4H, 16ELKC, 16ELL4, 16ELHK, 16ELL5, 16EK5N, 16ELL6, 16ELHL, 16ELUW, 16ELVJ, 16EK2K, 16ELTN, 16EK6X, 16EKXA, 16ELJL, 16ELTU, 16ELK5, 16EK7M, 16ELJ8, 16ELWL, 16ELVF, 16EMF6, 16EMF5, 16EMF7, 16EMEH, 16EMM4, 16EMF9, 16EMF4, 16EMEX, 16EMEF, 16EMKA, 16EMKX, 16EMDL, 16EMJH, 16EMJR, 16EMHD, 16EMLK, 16EMF3, 16EMDV, 16ENDE, 16ENEP, 16ENEU, 16ENL5, 16EP2L, 16ERJR, 16ERH4, 16ERHD, 16ERFJ, 16EREW, 16ERFM, 16ETU0, 16EV8R, 16EV70, 16ETUF, 16EUX2, 16ETRM, 16EU0L, 16EU0D, 16EV6N, 16ETVH, 16EUYH, 16EUW9, 16EUYF, 16EUVV, 16ETTN, 16EUVH, 16EUW3, 16ETYJ, 16EU10, 16EUWU, 16EUXF, 16EUXD, 16ETWM, 16EV75, 16EXEL, 16EXFU, 16EXEM, 16EW64, 16EW69, 16EW6F, 16EW7R, 16EW6V, 16EY12, 16EW8U, 16EW87, 16EW9T, 16EXXW, 16EXEX, 16EW8X, 16EXEU, 16EXX7, 16EXXN, 16EXET, 16EXEY, 16EXFN, 16EW92, 16EXDD, 16F029, 16F1X4, 16F1X5, 16F01P, 16F0AJ, 16F02R, 16F04P, 16F1M8, 16F29M, 16F27J, 16F025, 16F1X2, 16F1XK, 16F25L, 16F1YA, 16F1X3, 16F1XM, 16F1YD, 16F3ED, 16F3L7, 16F3KX, 16F3E7, 16F3HA, 16F3FW, 16F3FX, 16F3F1, 16F4NR, 16F5A7, 16F5AT, 16F5C0, 16F5C4, 16F5AV, 16F5L4, 16F8DV, 16F898, 16F894, 16F897, 16F88C, 16F81V, 16F7YP, 16F7YE, 16F87M, 16F824, 16F7YY, 16F885, 16F9C9, 16F9C5, 16FAKC, 16F9C0, 16F97K, 16F9C8, 16F9C6, 16F9C3, 16F9C4, 16F9AW, 16F94J, 16F94Y, 16F93E, 16FA72, 16FA77, 16F951, 16FA76, 16FA80, 16FA87, 16FEDM, 16FD7L, 16FDJA, 16FDML, 16FD8K, 16FDMK, 16FDM0, 16FCA5, 16FD7A, 16FFCA, 16FHHT, 16FHHW, 16FHHY, 16FF8W, 16FF8Y, 16FHJ0, 16FF6F, 16FHHM, 16FHK6, 16FFDD, 16FF9K, 16FHJX, 16FJYD, 16FK01, 16FJY7, 16FJXP, 16FJYV, 16FJYY, 16FR4T, 16FPLA, 16FPK8, 16FPM5, 16FPJ7, 16FPKW, 16FPLK, 16FPKM, 16FPLX, 16FPJT, 16FPK7, 16FT82, 16FU60, 16FT73, 16FUY4, 16FT6R, 16FU82, 16FT74, 16FUY6, 16FT76, 16FT6W, 16FT8V, 16FTDC, 16FT8R, 16FU6D, 16FU8A, 16FT8F, 16FU91, 16FU8C, 16FU8U, 16FU6V, 16FU8L, 16FT80, 16FU75, 16FU65, 16FTD7, 16FU7C, 16FU69, 16FU5X, 16FT7H, 16FX5K, 16FW58, 16FX7D, 16FX7A, 16FX5R, 16FY2X, 16FX50, 16FVYE, 16FVYA, 16FX3X, 16FX56, 16FX4M, 16FVYM, 16FX3M, 16FX4T, 16FX32, 16FX7M, 16FX5U, 16FX4F, 16FX55, 16FX3H, 16H05C, 16H05D, 16H05E, 16H05F, 16H0AW, 16H0AL, 16H0C1, 16H0C5, 16H0C2, 16H0AU, 16H21C, 16H0A3, 16H0AY, 16H0C6, 16H05H, 16H210, 16H0CV, 16H0CW, 16H1HV, 16H03T, 16H1DY, 16H03X, 16H096, 16H09H, 16H041, 16H1CW, 16H1HW, 16H088, 16H0AH, 16H055, 16H1HR, 16H21F, 16H047, 16H09V, 16H0CA, 16H1CU, 16H1E3, 16H1HL, 16H1DD, 16H03P, 16H21H, 16H2XN, 16H37U, 16H30U, 16H2Y5, 16H2YA, 16H2YH, 16H4AC, 16H340, 16H302, 16H2Y4, 16H49A, 16H2Y0, 16H4A5, 16H49E, 16H33D, 16H36M, 16H2XW, 16H30E, 16H49P, 16H4AM, 16H4A1, 16H2XX, 16H360, 16H5F7, 16H5EV, 16H5FE, 16H5E7, 16H5FF, 16H5ER, 16H7A3, 16H7A4, 16H79C, 16H78K, 16H7CF, 16H79P, 16H791, 16H79U, 16H7A9, 16H7C8, 16H9F1, 16H9J5, 16H9TA, 16H9FX, 16H9KA, 16H9RU, 16H9TR, 16H9TX, 16HCKE, 16HCFC, 16HCP7, 16HCCW, 16HCDF, 16HCFJ, 16HE8N, 16HE83, 16HE8K, 16HDRC, 16HCK2, 16HCKH, 16HCKC, 16HDPR

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 5 of 36

Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2649-2024

Recall number: Z-2649-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 5,039 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065771541; UDI-DI: 00380657715411; Lot numbers: 168NME, 168NND, 16AV17.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 6 of 36

Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2650-2024

Recall number: Z-2650-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 13,824 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065772245; UDI-DI: 00380657722457; Lot numbers: 15P7PW, 15TFMD, 15TFME, 15TFMF, 15W7U4, 15W7U5, 15W7U6, 15W7U7, 15W7U8, 15W993, 169KKN, 169KKP, 169KKR, 169KKT, 169KRX.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 7 of 36

Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2651-2024

Recall number: Z-2651-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 1,152 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065772265; UDI-DI: 00380657722655; Lot numbers: 15P7RH, 15P7RK, 15TFMJ, 15V034.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 8 of 36

Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2652-2024

Recall number: Z-2652-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 29,814 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065772445; UDI-DI: 00380657724451; Lot numbers: 15V018, 15V019, 15V01A, 15V01C, 15V01D, 15V036, 15W7UE, 15W7UF, 15W7UH, 15W7UJ, 15W996, 15W997, 161960, 161961, 161962, 161963, 167PR0, 167PT9, 168NM5, 168NM6, 168NM7, 168NN9, 168NNA, 168NNC, 168YFW, 169KL0, 169KL1, 169KL2, 169KL3, 169KTC, 169KTE, 169KTH.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 9 of 36

Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2653-2024

Recall number: Z-2653-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 1,932 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065772465; UDI-DI: 00380657724659; Lot numbers: 15P7RN, 15TFMK.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 10 of 36

Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2654-2024

Recall number: Z-2654-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 18,726 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065772745; UDI-DI: 00380657724659; Lot numbers: 1668AM, 1668CX, 167PPX, 167PPY, 167PT5, 168NM3, 168NM4, 168NMW, 168NMX, 169KT6, 169KKV, 169KT5, 16ALNW, 16AUL2, 16DDRC, 16DDY6, 16DDY7, 16DDYW, 16F206, 16DDYV, 16FXK8.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 11 of 36

Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2655-2024

Recall number: Z-2655-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 14,216 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065911901; UDI-DI: 00380659119019; Lot numbers: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, 16J9AE.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 12 of 36

Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2656-2024

Recall number: Z-2656-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 39,954 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065912001; UDI-DI: 00380659120015; Lot numbers: 15W9CJ, 161A10, 161A2M, 163701, 164WWX, 16D4VU.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 13 of 36

Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2657-2024

Recall number: Z-2657-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 469,173 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065921541; UDI-DI: 00380659215414; Lot numbers: 15W7XT, 15W7Y8, 15W7Y9, 15W9E6, 15W9E8, 15X5JJ, 15X56A, 15X56C, 15X5KV, 15X5KX, 1618UH, 1618UJ, 161A1K, 1618V4, 1618V5, 161A21, 161A22, 162WY5, 162WY6, 162WYL, 162WYN, 1636Y8, 1636Y9, 1636YV, 164RXL, 164RY8, 164RYA, 164WV3, 164WW9, 164WWC, 1668MR, 1668MT, 1668NH, 1668NJ, 1668NK, 166E89, 166E90, 166E91, 167PVK, 167R34, 167PW7, 167PW8, 167PW9, 167R3K, 167R3L, 168TE8, 168UEX, 168TEN, 168UFJ, 168UFL, 169L38, 169L3M, 169P3C, 169P3D, 16ALXE, 16ALXF, 16AM34, 16ALY0, 16AM36, 16AV03, 16AV1T, 16DFKA, 16DFXT, 16DFL0, 16DFY7, 16DFY8, 16DNJ4, 16DNJN, 16DNJP, 16DNP3, 16DNP4, 16EM6V, 16EM6W, 16JAVH, 16JAVJ, 16JAVK, 16JAVL, 16JAVM.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 14 of 36

Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2658-2024

Recall number: Z-2658-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 6,020 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065982465; UDI-DI: 00380659824654; Lot number: 169L42

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 15 of 36

Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2659-2024

Recall number: Z-2659-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 2,520 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065983065; UDI-DI: 00380659830655; Lot number: 164RY1.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 16 of 36

Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2660-2024

Recall number: Z-2660-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 7,598 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065983265; UDI-DI: 00380659832659; Lot numbers: 16JV6H, 16DFL3.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 17 of 36

Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2661-2024

Recall number: Z-2661-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 9,384 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065990002; UDI-DI: 00380659900020; Lot numbers: 169L2V, 16H1KP.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 18 of 36

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2662-2024

Recall number: Z-2662-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 11,916 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992245; UDI-DI: 00380659924453; Lot numbers: 168UH0, 16H1L6.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 19 of 36

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2663-2024

Recall number: Z-2663-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 35,199 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992445; UDI-DI: 00380659924453; Lot numbers: 169P2R, 16AV06, 16AV1Y, 16F1JU, 16K9HA, 167R42.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 20 of 36

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2664-2024

Recall number: Z-2664-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 3,419 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992561; UDI-DI: 00380659925610; Lot number: 16ALWU.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 21 of 36

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2665-2024

Recall number: Z-2665-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 5,487 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992647; UDI-DI: 00380659926471; Lot number: 15X5KP.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 22 of 36

Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2666-2024

Recall number: Z-2666-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 145,248 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992745; UDI-DI: 00380659927454; Lot numbers: 15X55P, 161A1C, 162WXV, 162WXW, 162WXX, 1636Y1, 1668MJ, 1668MK, 167R2Y, 168UEV, 16DFK6, 16DFXL, 16DNHY, 16EV4J, 16EV4K, 16F1PT, 16FXNX, 16FXNY, 16H1K6, 16J7UC, 1668NN, 169P3F, 16AM3T, 16AV0F, 16DFY9, 16EV4N.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 23 of 36

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2667-2024

Recall number: Z-2667-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 53,123 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992747; UDI-DI: 00380659927478; Lot numbers: 1636Y0, 164RX6, 166E81, 166E82, 16ALX5, 16DNMV, 1618V6, 16AM3U, 16AV0E.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 24 of 36

Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2668-2024

Recall number: Z-2668-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 30,268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065992761; UDI-DI: 00380659927614; Lot numbers: 1636XM, 16EV4H, 1618VR, 167PWV, 16J7VA.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 25 of 36

Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2669-2024

Recall number: Z-2669-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 11,676 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065993045; UDI-DI: 00380659930454; Lot numbers: 164RXE, 16F1PX.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 26 of 36

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Z-2670-2024

Recall number: Z-2670-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 15,222 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065993047; UDI-DI: 00380659930478; Lot numbers: 1668MH, 16AUYX, 16DNHX.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 27 of 36

Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A

Z-2671-2024

Recall number: Z-2671-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 7,713 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065000095; UDI-DI: 380650000958; Lot numbers: 16D1KR, 16D1KU, 16D1KV, 16D1KW, 16D1KX, 16FX1P, 16FX1R, 16HYDY, 16HYE0, 16HYE1.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 28 of 36

Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A

Z-2672-2024

Recall number: Z-2672-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 1,061 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065000093; UDI-DI: 380650000934; Lot numbers: 16HY6X.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 29 of 36

Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A

Z-2673-2024

Recall number: Z-2673-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 3,197 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065751617; UDI-DI: 380657516179; Lot numbers: 16D1KA, 16D1KC, 16HE5E.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 30 of 36

Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

Z-2674-2024

Recall number: Z-2674-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 324 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065751618; UDI-DI: 380657516186; Lot number: 16D1KN.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 31 of 36

Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A

Z-2675-2024

Recall number: Z-2675-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 3,791 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065751767; UDI-DI: 380657517671; Lot numbers: 16C9ND, 16C9NE, 16C9NF, 16HE5R, 16HYDK.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 32 of 36

Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

Z-2676-2024

Recall number: Z-2676-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 7,108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065752437; UDI-DI: 380657524372; Lot numbers: 16AUM5, 16C9RE, 16DDFN, 16HE6A, 16HYDP, 16HYDR, 16HYDT.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 33 of 36

Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A

Z-2677-2024

Recall number: Z-2677-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 4,766 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065752438; UDI-DI: 380657524389; Lot numbers: 16C9RF, 16DDFT, 16DDFU, 16HE6E, 16HE6F, 16HYDW.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 34 of 36

Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A

Z-2678-2024

Recall number: Z-2678-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 1,057 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065752450; UDI-DI: 380657524501; Lot number: 16C9P7.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 35 of 36

Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

Z-2679-2024

Recall number: Z-2679-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 4,481 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065752451; UDI-DI: 380657524518; Lot numbers: 16AUN4, 16AUN3, 16C9PX, 16C9PY, 16C9R0.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

device · product 36 of 36

Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A

Z-2680-2024

Recall number: Z-2680-2024
Initiated: July 15, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Alcon Research LLC
Quantity: 6,972 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Code information

Model/Catalog Number: 8065753106; UDI-DI: 380657531066; Lot numbers: 16A6HW, 16A6HX, 16A6HY, 16AUNE, 16C9R3, 16HYFF, 16HYFJ.

Distribution pattern

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

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