Reported Dec 13, 2023 · Ongoing

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. 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_13.2. Phakic Toric Intraocular lens
Lot codes and dates

11 of 11 products

Products covered by this recall
#BarcodesProduct as published
100841542116152T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122
200841542115735T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436
300841542116169T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531
400841542115933T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550
500841542116053T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722
600841542116299T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957
700841542116992T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243
800841542116305T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644
900841542116763T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475
1000841542116411T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400
1100841542116534T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382
Amount recalled
11 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.

Free recall alerts

Get alerted about new Staar Surgical Company recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:34 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.