Reported Mar 20, 2013 · Terminated

AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are…

Abbott Medical Optics Inc. (AMO)

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: Abbott Medical Optics Inc (AMO) · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933

Is this the product you have?

  • AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable
  • IOL with OptiEdge Product UsageThese are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction
Lot codes and dates
  • Diopter

    78 of 78 codes

    • 18.0
    • 4760271207
    • 4760661207
    • 4761191207
    • 4760281207
    • 4760681207
    • 4761211207
    • 4760291207
    • 4760701207
    • 4761221207
    • 4760301207
    • 4760721207
    • 4761231207
    • 4760311207
    • 4760741207
    • 4761241207
    • 4760321207
    • 4760761207
    • 4761251207
    • 4760331207
    • 4760781207
    • 4761261207
    • 4760341207
    • 4760801207
    • 4761271207
    • 4760351207
    • 4760811207
    • 4761281207
    • 4760361207
    • 4760821207
    • 4760371207
    • 4760841207
    • 4760381207
    • 4760861207
    • 4760391207
    • 4760881207
    • 4760401207
    • 4760901207
    • 4760411207
    • 4760921207
    • 4760421207
    • 4760941207
    • 4760431207
    • 4760961207
    • 4760441207
    • 4760981207
    • 4760451207
    • 4761001207
    • 4760461207
    • 4761031207
    • 4760471207
    • 4761041207
    • 4760481207
    • 4761051207
    • 4760491207
    • 4761061207
    • 4760501207
    • 4761071207
    • 4760511207
    • 4761081207
    Diopter

    79 of 79 codes

    • 23.5
    • 4759221207
    • 4759821207
    • 4760161207
    • 4759231207
    • 4759831207
    • 4760171207
    • 4759241207
    • 4759841207
    • 4760181207
    • 4759251207
    • 4759851207
    • 4760191207
    • 4759261207
    • 4759861207
    • 4760201207
    • 4759271207
    • 4759871207
    • 4760211207
    • 4759281207
    • 4759881207
    • 4760221207
    • 4759291207
    • 4759891207
    • 4760231207
    • 4759311207
    • 4759901207
    • 4760241207
    • 4759321207
    • 4759911207
    • 4760251207
    • 4759331207
    • 4759921207
    • 4759341207
    • 4759931207
    • 4759361207
    • 4759941207
    • 4759381207
    • 4759951207
    • 4759401207
    • 4759961207
    • 4759421207
    • 4759971207
    • 4759441207
    • 4759981207
    • 4759461207
    • 4759991207
    • 4759481207
    • 4760001207
    • 4759671207
    • 4760011207
    • 4759681207
    • 4760021207
    • 4759691207
    • 4760031207
    • 4759701207
    • 4760041207
    • 4759711207
    • 4760051207
    • 4759721207
Amount recalled
155 units

Where it was sold

  • Nationwide
  • OH

Why it was recalled

Two production orders of these IOLs that contain mislabeled IOLs.

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

Notice updated Jan 8, 2014 · Data as of Sep 19, 6:54 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.