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
#BarcodesProduct as published
100841542119429S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405
200841542119375S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843
300841542119429S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482
400841542119375S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360
500841542119443S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652
600841542119375S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367
700841542119399S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265
800841542119375S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309
900841542119429S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419
1000841542119436S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618
1100841542119405S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641
1200841542119443S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701
1300841542119450S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801
1400841542119375S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411
1500841542119382S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798
1600841542119320S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122
1700841542119405S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409
1800841542119429S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428
1900841542119375S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891
2000841542119436S1765467/ (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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.