Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. 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_12.6. Phakic Toric Intraocular lens
- Lot codes and dates
15 of 15 products
Products covered by this recall # Barcodes Product as published 1 00841542114141T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975 2 00841542115506T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082 3 00841542115544T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541 4 00841542115469T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771 5 00841542115537T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561 6 00841542114615T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995 7 00841542115506T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648 8 00841542115247T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982 9 00841542114776T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552 10 00841542115209T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773 11 00841542114530T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414 12 00841542114349T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808 13 00841542115384T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554 14 00841542114981T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152 15 00841542114950T1566889/ (01)00841542114950(11)230629(17)250531(21)T1566889 - Amount recalled
- 15 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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