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
#BarcodesProduct as published
100841542114141T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975
200841542115506T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082
300841542115544T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541
400841542115469T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771
500841542115537T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561
600841542114615T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995
700841542115506T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648
800841542115247T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982
900841542114776T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552
1000841542115209T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773
1100841542114530T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414
1200841542114349T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808
1300841542115384T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554
1400841542114981T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152
1500841542114950T1566889/ (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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:17 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.