Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. 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_12.1. Phakic Toric Intraocular lens
- Lot codes and dates
3 of 3 products · 3 lot codes
Recalled lot codes, grouped by product number Serial UDI T1366733(01)00841542113809(11)230215(17)250131(21)T1366733
T1485721(01)00841542113892(11)230503(17)250430(21)T1485721
T1347685(01)00841542113700(11)230203(17)250131(21)T1347685
- Amount recalled
- 3 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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