Reported Nov 18, 2015 · Terminated

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

Tekia, Inc.

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: Tekia, Inc. · 17 Hammond Ste 414 · Irvine, CA · 92618-1635

Is this the product you have?

  • TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Lot codes and dates
  • SN
    • U07310001 thru U07310040
    • 07310050 thru U07310059
Amount recalled
50 units

Why it was recalled

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 3, 2015 · Data as of Sep 19, 5:19 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.