Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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_12.6. Phakic Intraocular lens
- Lot codes and dates
133 of 133 products
Products covered by this recall # Barcodes Product as published 1 00841542119214S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386 2 00841542119139S1767226/(01)00841542119139(11)221207(17)241130(21)S1767226 3 00841542119146S1829207/(01)00841542119146(11)230205(17)250131(21)S1829207 4 00841542119214S1731401/(01)00841542119214(11)221109(17)241031(21)S1731401 5 00841542119214S1731432/(01)00841542119214(11)221109(17)241031(21)S1731432 6 00841542119177S1743481/(01)00841542119177(11)221117(17)241031(21)S1743481 7 00841542119139S1767274/(01)00841542119139(11)221207(17)241130(21)S1767274 8 00841542119153S1752570/(01)00841542119153(11)221123(17)241031(21)S1752570 9 00841542119177S1743474/(01)00841542119177(11)221117(17)241031(21)S1743474 10 00841542119221S1731493/(01)00841542119221(11)221109(17)241031(21)S1731493 11 00841542119153S1752526/(01)00841542119153(11)221123(17)241031(21)S1752526 12 00841542119160S1752533/(01)00841542119160(11)221123(17)241031(21)S1752533 13 00841542119153S1752529/(01)00841542119153(11)221123(17)241031(21)S1752529 14 00841542119191S1732703/(01)00841542119191(11)221110(17)241031(21)S1732703 15 00841542119139S1767229/(01)00841542119139(11)221207(17)241130(21)S1767229 16 00841542119122S1832551/(01)00841542119122(11)230208(17)250131(21)S1832551 17 00841542119177S1743500/(01)00841542119177(11)221117(17)241031(21)S1743500 18 00841542119221S1731502/(01)00841542119221(11)221109(17)241031(21)S1731502 19 00841542119108S1752370/(01)00841542119108(11)221123(17)241031(21)S1752370 20 00841542119214S1731407/(01)00841542119214(11)221109(17)241031(21)S1731407 - Amount recalled
- 133 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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