Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic 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
- REFVICM5_13.2. Phakic Intraocular lens
- Lot codes and dates
51 of 51 products
Products covered by this recall # Barcodes Product as published 1 00841542119429S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405 2 00841542119375S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843 3 00841542119429S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482 4 00841542119375S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360 5 00841542119443S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652 6 00841542119375S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367 7 00841542119399S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265 8 00841542119375S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309 9 00841542119429S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419 10 00841542119436S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618 11 00841542119405S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641 12 00841542119443S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701 13 00841542119450S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801 14 00841542119375S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411 15 00841542119382S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798 16 00841542119320S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122 17 00841542119405S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409 18 00841542119429S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428 19 00841542119375S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891 20 00841542119436S1765467/ (01)00841542119436(11)221205(17)241130(21)S1765467 - Amount recalled
- 51 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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