Recall archive / FDA device enforcement
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. — FDA record Z-0466-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Reason
- Their is a potential that intraocular implant devices may not meet specifications.
- Classification
- Class II
- Recalling firm
- Staar Surgical Company
- Quantity
- 51 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0466-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
Dates in the source
- Report date
- Dec 13, 2023
- Recall initiation date
- Sep 29, 2023
- Center classification date
- Dec 1, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.