Staar Surgical Company: EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

Hazard

Their is a potential that intraocular implant devices may not meet specifications.

Details from the source

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 Quantity: 15 UNITS Lot/code info: 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

UPC codes

00841542114141, 00841542115506, 00841542115544, 00841542115469, 00841542115537, 00841542114615, 00841542115247, 00841542114776, 00841542115209, 00841542114530, 00841542114349, 00841542115384, 00841542114981, 00841542114950

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.