EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Company
- Staar Surgical Company
- Recall Initiated
- September 29, 2023
- Posted
- December 1, 2023
- Recall Number
- Z-0466-2024
- Quantity
- 51 units
- Firm Location
- Monrovia, CA
Reason for Recall
Their is a potential that intraocular implant devices may not meet specifications.
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
Lot / Code Info
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
Root Cause
Software design (manufacturing process)
Action Taken
On October 25, 2023, Staar Surgical issued a "Urgent: Medical Device Voluntary Recall" notification to affected consignees. Staar Surgical ask consignees to take the following actions: 1. Review your current inventory of STAAR EVO/EVO+ devices. 2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the product. 3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession. 4. Fax the form within 5 days upon receipt of this notification to: 1-800-952-4923 or email a pdf copy of the form to: atramontana@staar.com. 5. Return the EVO/EVO+ device(s) with the Medical Device Recall Return Response form to STAAR Surgical using the prepaid postage to the address identified in the attached Medical Device Recall Return Response form. 6. Apply the enclosed sticker/label "Attn: Recall Coordinator" to the outside of each ICL box being returned to STAAR Surgical. 7. Affected product and distribution information specific to your facility is contained in the Medical Device Recall Return Response Form