Reported Dec 13, 2023 · Ongoing

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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_13.7.Phakic Intraocular lens
Lot codes and dates
  • UDI(01)00841542119696(11)221031(17)240930(21)S1721962/
  • Serial NumberS1721962
Amount recalled
1 unit

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.