Staar Surgical Company: EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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: 133 units Lot/code info: Serial Number/UDI: S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386; S1767226/(01)00841542119139(11)221207(17)241130(21)S1767226; S1829207/(01)00841542119146(11)230205(17)250131(21)S1829207; S1731401/(01)00841542119214(11)221109(17)241031(21)S1731401; S1731432/(01)00841542119214(11)221109(17)241031(21)S1731432; S1743481/(01)00841542119177(11)221117(17)241031(21)S1743481; S1767274/(01)00841542119139(11)221207(17)241130(21)S1767274; S1752570/(01)00841542119153(11)221123(17)241031(21)S1752570; S1743474/(01)00841542119177(11)221117(17)241031(21)S1743474; S1731493/(01)00841542119221(11)221109(17)241031(21)S1731493; S1752526/(01)00841542119153(11)221123(17)241031(21)S1752526; S1752533/(01)00841542119160(11)221123(17)241031(21)S1752533; S1752529/(01)00841542119153(11)221123(17)241031(21)S1752529; S1732703/(01)00841542119191(11)221110(17)241031(21)S1732703; S1767229/(01)00841542119139(11)221207(17)241130(21)S1767229; S1832551/(01)00841542119122(11)230208(17)250131(21)S1832551; S1743500/(01)00841542119177(11)221117(17)241031(21)S1743500; S1731502/(01)00841542119221(11)221109(17)241031(21)S1731502; S1752370/(01)00841542119108(11)221123(17)241031(21)S1752370; S1731407/(01)00841542119214(11)221109(17)241031(21)S1731407; S1767262/(01)00841542119139(11)221207(17)241130(21)S1767262; S1731477/(01)00841542119221(11)221109(17)241031(21)S1731477; S1731483/(01)00841542119221(11)221109(17)241031(21)S1731483; S1731391/(01)00841542119214(11)221109(17)241031(21)S1731391; S1767278/(01)0084

UPC codes

00841542119214, 00841542119139, 00841542119146, 00841542119177, 00841542119153, 00841542119221, 00841542119160, 00841542119191, 00841542119122, 00841542119108, 00841542119207, 00841542119092, 00841542119184, 00841542119115, 00841542119269, 00841542119252, 00841542119245, 00841542119238, 00841542119085

Source

Official record: FDA (Device enforcement) ↗

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