Staar Surgical Company: EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic 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: 20 units Lot/code info: Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863; S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689; S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624; S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602; S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625; S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793; S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627; S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889; S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554; S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274; S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126; S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633; S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475; S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018; S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365; S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112; S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884; S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691; S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278

UPC codes

00841542118965, 00841542118958, 00841542118910, 00841542118873, 00841542118927, 00841542119030, 00841542118972, 00841542118934, 00841542118897

Source

Official record: FDA (Device enforcement) ↗

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