Reported Jul 24, 2013 · Terminated

Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a…

Staar Surgical Co.

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 Co. · 1911 Walker Ave · Monrovia, CA · 91016-4846

Is this the product you have?

  • Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Lot codes and dates
  • Serial Numbers

    644 of 644 codes

    • B377178
    • B377469
    • B377877
    • B378928
    • B379032
    • B379638
    • B380197
    • B380796
    • B377192
    • B377473
    • B377879
    • B378940
    • B379048
    • B379643
    • B380200
    • B380800
    • B377193
    • B377480
    • B377880
    • B378945
    • B379062
    • B379645
    • B380206
    • B380801
    • B377194
    • B377481
    • B377883
    • B378946
    • B379063
    • B379646
    • B380208
    • B380803
    • B377195
    • B377482
    • B377885
    • B378947
    • B379066
    • B379650
    • B380214
    • B380807
    • B377196
    • B377485
    • B377887
    • B378949
    • B379093
    • B379652
    • B380227
    • B380816
    • B377197
    • B377487
    • B377888
    • B378951
    • B379095
    • B379653
    • B380230
    • B381000
    • B377200
    • B377488
    • B377889
    • B378953
Amount recalled
3,361 units total

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.

This product could cause temporary or reversible health problems — stop using it.

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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

Notice updated Oct 17, 2013 · Data as of Sep 19, 5:32 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.