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

Staar Surgical Company: EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. 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: 6 UNITS Lot/code info: T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478; T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985; T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704; T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322; T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546; T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195

UPC codes

00841542118378, 00841542118316, 00841542118330, 00841542118347, 00841542118644, 00841542118149

Source

Official record: FDA (Device enforcement)

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

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