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FDA (Device enforcement)Recalled 2023-09-29class ii

Staar Surgical Company: EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. 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: 11 UNITS Lot/code info: 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

UPC codes

00841542116152, 00841542115735, 00841542116169, 00841542115933, 00841542116053, 00841542116299, 00841542116992, 00841542116305, 00841542116763, 00841542116411, 00841542116534

Source

Official record: FDA (Device enforcement)

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

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