medical Class II Updated 2023-12-13

Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Pha

Recalled Product

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.


Hazard / Issue

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

Issued by

FDA

Affected States: 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
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
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