EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

Class I - Dangerous

🏥 Medical Devices Recalled: September 29, 2023 Staar Surgical Company Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Staar Surgical Company
Reason for Recall:: Their is a potential that intraocular implant devices may not meet specifications.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

Product Codes/Lot Numbers:

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