Recall events
/
Event 93312
Event summary
Timeline bucket September 29, 2023
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Staar Surgical Company
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
11 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 11
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Z-0464-2024
Recall number Z-0464-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0464-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5112]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863; S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689; S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624; S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602; S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625; S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793; S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627; S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889; S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554; S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274; S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126; S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633; S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475; S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018; S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365; S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112; S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884; S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691; S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6388]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 11
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Z-0465-2024
Recall number Z-0465-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 133 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0465-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52328]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial Number/UDI: S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386; S1767226/(01)00841542119139(11)221207(17)241130(21)S1767226; S1829207/(01)00841542119146(11)230205(17)250131(21)S1829207; S1731401/(01)00841542119214(11)221109(17)241031(21)S1731401; S1731432/(01)00841542119214(11)221109(17)241031(21)S1731432; S1743481/(01)00841542119177(11)221117(17)241031(21)S1743481; S1767274/(01)00841542119139(11)221207(17)241130(21)S1767274; S1752570/(01)00841542119153(11)221123(17)241031(21)S1752570; S1743474/(01)00841542119177(11)221117(17)241031(21)S1743474; S1731493/(01)00841542119221(11)221109(17)241031(21)S1731493; S1752526/(01)00841542119153(11)221123(17)241031(21)S1752526; S1752533/(01)00841542119160(11)221123(17)241031(21)S1752533; S1752529/(01)00841542119153(11)221123(17)241031(21)S1752529; S1732703/(01)00841542119191(11)221110(17)241031(21)S1732703; S1767229/(01)00841542119139(11)221207(17)241130(21)S1767229; S1832551/(01)00841542119122(11)230208(17)250131(21)S1832551; S1743500/(01)00841542119177(11)221117(17)241031(21)S1743500; S1731502/(01)00841542119221(11)221109(17)241031(21)S1731502; S1752370/(01)00841542119108(11)221123(17)241031(21)S1752370; S1731407/(01)00841542119214(11)221109(17)241031(21)S1731407; S1767262/(01)00841542119139(11)221207(17)241130(21)S1767262; S1731477/(01)00841542119221(11)221109(17)241031(21)S1731477; S1731483/(01)00841542119221(11)221109(17)241031(21)S1731483; S1731391/(01)00841542119214(11)221109(17)241031(21)S1731391; S1767278/(01)00841542119139(11)221207(17)241130(21)S1767278; S1752513/(01)00841542119153(11)221123(17)241031(21)S1752513; S1882887/(01)00841542119122(11)230321(17)250228(21)S1882887; S1868138/(01)00841542119108(11)230306(17)250228(21)S1868138; S1767235/(01)00841542119139(11)221207(17)241130(21)S1767235; S1752520/(01)00841542119153(11)221123(17)241031(21)S1752520; S1731469/(01)00841542119221(11)221109(17)241031(21)S1731469; S1866689/(01)00841542119214(11)230305(17)250228(21)S1866689; S1731459/(01)00841542119221(11)221109(17)241031(21)S1731459; S1752601/(01)00841542119153(11)221123(17)241031(21)S1752601; S1945398/(01)00841542119207(11)230504(17)250430(21)S1945398; S1752585/(01)00841542119153(11)221123(17)241031(21)S1752585; S1732727/(01)00841542119191(11)221110(17)241031(21)S1732727; S1731463/(01)00841542119221(11)221109(17)241031(21)S1731463; S1731404/(01)00841542119214(11)221109(17)241031(21)S1731404; S1731497/(01)00841542119221(11)221109(17)241031(21)S1731497; S1743504/(01)00841542119177(11)221117(17)241031(21)S1743504; S1767232/(01)00841542119139(11)221207(17)241130(21)S1767232; S1829172/(01)00841542119146(11)230205(17)250131(21)S1829172; S1752348/(01)00841542119108(11)221123(17)241031(21)S1752348; S1829156/(01)00841542119146(11)230205(17)250131(21)S1829156; S1732741/(01)00841542119191(11)221110(17)241031(21)S1732741; S1731473/(01)00841542119221(11)221109(17)241031(21)S1731473; S1752554/(01)00841542119153(11)221123(17)241031(21)S1752554; S1752558/(01)00841542119153(11)221123(17)241031(21)S1752558; S1752548/(01)00841542119153(11)221123(17)241031(21)S1752548; S1700942/(01)00841542119092(11)221017(17)240930(21)S1700942; S1868092/(01)00841542119108(11)230306(17)250228(21)S1868092; S1868101/(01)00841542119108(11)230306(17)250228(21)S1868101; S1829192/(01)00841542119146(11)230205(17)250131(21)S1829192; S1732716/(01)00841542119191(11)221110(17)241031(21)S1732716; S1730908/(01)00841542119177(11)221109(17)241031(21)S1730908; S1731485/(01)00841542119221(11)221109(17)241031(21)S1731485; S1752405/(01)00841542119108(11)221123(17)241031(21)S1752405; S1745071/(01)00841542119184(11)221119(17)241031(21)S1745071; S1732713/(01)00841542119191(11)221110(17)241031(21)S1732713; S1767280/(01)00841542119139(11)221207(17)241130(21)S1767280; S1721733/(01)00841542119207(11)221031(17)240930(21)S1721733; S1879237/(01)00841542119184(11)230317(17)250228(21)S1879237; S1857487/(01)00841542119221(11)230225(17)250131(21)S1857487; S1767245/(01)00841542119139(11)221207(17)241130(21)S1767245; S1731490/(01)00841542119221(11)221109(17)241031(21)S1731490; S1732698/(01)00841542119191(11)221110(17)241031(21)S1732698; S1725803/(01)00841542119115(11)221103(17)241031(21)S1725803; S1767343/(01)00841542119184(11)221207(17)241130(21)S1767343; S1723503/(01)00841542119160(11)221101(17)240930(21)S1723503; S1767282/(01)00841542119139(11)221207(17)241130(21)S1767282; S1882875/(01)00841542119139(11)230321(17)250228(21)S1882875; S1743476/(01)00841542119177(11)221117(17)241031(21)S1743476; S1743482/(01)00841542119177(11)221117(17)241031(21)S1743482; S1732708/(01)00841542119191(11)221110(17)241031(21)S1732708; S1730972/(01)00841542119214(11)221109(17)241031(21)S1730972; S1767297/(01)00841542119184(11)221207(17)241130(21)S1767297; S1829150/(01)00841542119153(11)230205(17)250131(21)S1829150; S1829181/(01)00841542119153(11)230205(17)250131(21)S1829181; S1732237/(01)00841542119146(11)221110(17)241031(21)S1732237; S1721749/(01)00841542119207(11)221031(17)240930(21)S1721749; S1767311/(01)00841542119177(11)221207(17)241130(21)S1767311; S1767251/(01)00841542119139(11)221207(17)241130(21)S1767251; S1878254/(01)00841542119177(11)230316(17)250228(21)S1878254; S1767310/(01)00841542119177(11)221207(17)241130(21)S1767310; S1732721/(01)00841542119207(11)221110(17)241031(21)S1732721; S1731451/(01)00841542119221(11)221109(17)241031(21)S1731451; S1696028/(01)00841542119092(11)221013(17)240930(21)S1696028; S1857547/(01)00841542119191(11)230225(17)250131(21)S1857547; S1743538/(01)00841542119177(11)221117(17)241031(21)S1743538; S1752552/(01)00841542119153(11)221123(17)241031(21)S1752552; S1731453/(01)00841542119221(11)221109(17)241031(21)S1731453; S1878296/(01)00841542119269(11)230316(17)250228(21)S1878296; S1746676/(01)00841542119252(11)221120(17)241031(21)S1746676; S1731395/(01)00841542119207(11)221109(17)241031(21)S1731395; S1829158/(01)00841542119146(11)230205(17)250131(21)S1829158; S1732724/(01)00841542119191(11)221110(17)241031(21)S1732724; S1723512/(01)00841542119160(11)221101(17)240930(21)S1723512; S1746615/(01)00841542119245(11)221120(17)241031(21)S1746615; S1767302/(01)00841542119177(11)221207(17)241130(21)S1767302; S1731450/(01)00841542119221(11)221109(17)241031(21)S1731450; S1746631/(01)00841542119238(11)221120(17)241031(21)S1746631; S1767249/(01)00841542119139(11)221207(17)241130(21)S1767249; S1746662/(01)00841542119252(11)221120(17)241031(21)S1746662; S1752605/(01)00841542119153(11)221123(17)241031(21)S1752605; S1732714/(01)00841542119191(11)221110(17)241031(21)S1732714; S1774355/(01)00841542119146(11)221216(17)241130(21)S1774355; S1767216/(01)00841542119139(11)221207(17)241130(21)S1767216; S1767320/(01)00841542119177(11)221207(17)241130(21)S1767320; S1767258/(01)00841542119139(11)221207(17)241130(21)S1767258; S1743484/(01)00841542119177(11)221117(17)241031(21)S1743484; S1743499/(01)00841542119177(11)221117(17)241031(21)S1743499; S1743492/(01)00841542119177(11)221117(17)241031(21)S1743492; S1732171/(01)00841542119139(11)221110(17)241031(21)S1732171; S1734432/(01)00841542119245(11)221112(17)241031(21)S1734432; S1767260/(01)00841542119146(11)221207(17)241130(21)S1767260; S1868157/(01)00841542119108(11)230306(17)250228(21)S1868157; S1684674/(01)00841542119085(11)221005(17)240930(21)S1684674; S1765676/(01)00841542119153(11)221205(17)241130(21)S1765676; S1752408/(01)00841542119108(11)221123(17)241031(21)S1752408; S1725736/(01)00841542119115(11)221103(17)241031(21)S1725736; S1725740/(01)00841542119115(11)221103(17)241031(21)S1725740; S1866950/(01)00841542119153(11)230305(17)250228(21)S1866950; S1752579/(01)00841542119153(11)221123(17)241031(21)S1752579; S1734412/(01)00841542119245(11)221112(17)241031(21)S1734412; S1704785/(01)00841542119092(11)221020(17)240930(21)S1704785; S1732734/(01)00841542119191(11)221110(17)241031(21)S1732734; S1876849/(01)00841542119139(11)230313(17)250228(21)S1876849; S1732162/(01)00841542119139(11)221110(17)241031(21)S1732162; S1700944/(01)00841542119092(11)221017(17)240930(21)S1700944; S1732684/(01)00841542119191(11)221110(17)241031(21)S1732684; S1725767/(01)00841542119115(11)221103(17)241031(21)S1725767; S1725763/(01)00841542119115(11)221103(17)241031(21)S1725763;
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6354]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 11
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Z-0466-2024
Recall number Z-0466-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 51 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0466-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16823]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405; S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843; S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482; S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360; S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652; S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367; S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265; S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309; S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419; S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618; S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641; S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701; S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801; S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411; S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798; S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122; S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409; S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428; S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891; S1765467/ (01)00841542119436(11)221205(17)241130(21)S1765467; S1765395/ (01)00841542119375(11)221205(17)241130(21)S1765395; S1721457/ (01)00841542119429(11)221031(17)240930(21)S1721457; S1721402/ (01)00841542119429(11)221031(17)240930(21)S1721402; S1721450/ (01)00841542119429(11)221031(17)240930(21)S1721450; S1733624/ (01)00841542119467(11)221111(17)241031(21)S1733624; S1733562/ (01)00841542119450(11)221111(17)241031(21)S1733562; S1876673/ (01)00841542119467(11)230313(17)250228(21)S1876673; S1765388/ (01)00841542119375(11)221205(17)241130(21)S1765388; S1729681/ (01)00841542119467(11)221107(17)241031(21)S1729681; S1746880/ (01)00841542119375(11)221120(17)241031(21)S1746880; S1721427/ (01)00841542119429(11)221031(17)240930(21)S1721427; S1721455/ (01)00841542119429(11)221031(17)240930(21)S1721455; S1729363/ (01)00841542119368(11)221107(17)241031(21)S1729363; S1957456/ (01)00841542119399(11)230515(17)250430(21)S1957456; S1721485/ (01)00841542119429(11)221031(17)240930(21)S1721485; S1876724/ (01)00841542119450(11)230313(17)250228(21)S1876724; S1718864/ (01)00841542119399(11)221030(17)240930(21)S1718864; S1875218/ (01)00841542119368(11)230312(17)250228(21)S1875218; S1746837/ (01)00841542119375(11)221120(17)241031(21)S1746837; S1721580/ (01)00841542119375(11)221031(17)240930(21)S1721580; S1721540/ (01)00841542119375(11)221031(17)240930(21)S1721540; S1729467/ (01)00841542119382(11)221107(17)241031(21)S1729467; S1765370/ (01)00841542119375(11)221205(17)241130(21)S1765370; S1765384/ (01)00841542119375(11)221205(17)241130(21)S1765384; S1878607/ (01)00841542119467(11)230316(17)250228(21)S1878607; S1724121/ (01)00841542119313(11)221102(17)241031(21)S1724121; S1746866/ (01)00841542119375(11)221120(17)241031(21)S1746866; S1733049/ (01)00841542119344(11)221110(17)241031(21)S1733049; S1729399/ (01)00841542119368(11)221107(17)241031(21)S1729399; S1669799/ (01)00841542119382(11)220922(17)240831(21)S1669799; S1721439/ (01)00841542119429(11)221031(17)240930(21)S1721439
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6337]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 11
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Z-0467-2024
Recall number Z-0467-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0467-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16846]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information UDI:(01)00841542119696(11)221031(17)240930(21)S1721962/ Serial Number: S1721962
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6420]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 11
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Z-0468-2024
Recall number Z-0468-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 1 UNIT
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0468-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5113]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information UDI:(01)00841542121972/ Serial Number: S1734493
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6857]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 11
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Z-0469-2024
Recall number Z-0469-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0469-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5109]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6438]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 11
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Z-0470-2024
Recall number Z-0470-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0470-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5116]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial/UDI: T1366733/(01)00841542113809(11)230215(17)250131(21)T1366733; T1485721/(01)00841542113892(11)230503(17)250430(21)T1485721; T1347685/(01)00841542113700(11)230203(17)250131(21)T1347685
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6243]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 11
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Z-0471-2024
Recall number Z-0471-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 15 UNITS
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0471-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9709]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975; T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082; T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541; T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771; T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561; T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995; T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648; T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982; T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552; T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773; T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414; T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808; T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554; T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152; T1566889/ (01)00841542114950(11)230629(17)250531(21)T1566889
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6368]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 11
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Z-0472-2024
Recall number Z-0472-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 11 UNITS
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0472-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5110]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122; T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436; T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531; T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550; T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722; T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957; T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243; T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644; T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475; T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400; T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6534]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0473-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 6 UNITS
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0473-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40165]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478; T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985; T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704; T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322; T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546; T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6204]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0474-2024
Initiated September 29, 2023
Classification Class II
Status Ongoing
Quantity 9 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
may not meet specifications
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0474-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57499]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is a potential that intraocular implant devices may not meet specifications.
Code information Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728; S1713542/ (01)00841542122030(11)221026(17)240930(21)S1713542; S1746725/ (01)00841542122016(11)221120(17)241031(21)S1746725; S1707067/ (01)00841542122016(11)221022(17)240930(21)S1707067; S1734035/ (01)00841542122047(11)221111(17)241031(21)S1734035; S1713494/ (01)00841542122030(11)221026(17)240930(21)S1713494; S1713551/ (01)00841542122030(11)221026(17)240930(21)S1713551; S1740887/ (01)00841542122047(11)221115(17)241031(21)S1740887; S1713505/ (01)00841542122030(11)221026(17)240930(21)S1713505
Distribution pattern US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
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[6340]
FDA event record
· Exact recall-number query on openFDA
