Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Staar Surgical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Staar Surgical Company · 1911 Walker Ave · Monrovia, CA · 91016-4846
Is this the product you have?
- EVO+VISIAN Implantable Collamer Lens
- REFVTICM5_13.2. Phakic Toric Intraocular lens
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 00841542116152T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122 2 00841542115735T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436 3 00841542116169T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531 4 00841542115933T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550 5 00841542116053T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722 6 00841542116299T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957 7 00841542116992T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243 8 00841542116305T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644 9 00841542116763T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475 10 00841542116411T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400 11 00841542116534T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382 - Amount recalled
- 11 UNITS
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Their is a potential that intraocular implant devices may not meet specifications.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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