Recall events
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Event 89111
Event summary
Timeline bucket November 17, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Beaver Visitec International, Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
6 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
Z-0405-2022
Recall number Z-0405-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 920 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0405-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4444]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7478]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 6
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Z-0406-2022
Recall number Z-0406-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 380 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0406-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51999]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3347921, 3358240
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7446]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 6
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Z-0407-2022
Recall number Z-0407-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 120 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0407-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51997]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3272267, 3274728, 3323887
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7313]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 6
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
Z-0408-2022
Recall number Z-0408-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0408-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16550]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3289074
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7419]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 6
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Z-0409-2022
Recall number Z-0409-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 680 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0409-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21787]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7612]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 6
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
Z-0410-2022
Recall number Z-0410-2022
Initiated November 17, 2021
Classification Class II
Status Ongoing
Quantity 1170 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Kit packaging may have small holes compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0410-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9360]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Kit packaging may have small holes compromising product sterility
Code information Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
Distribution pattern CA, CO, LA, MA, MD, ND, PA, TN, UT
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7520]
FDA event record
· Exact recall-number query on openFDA
