Reported Sep 28, 2016 · Terminated
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual…
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?
- SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
- Lot codes and dates
- Serial No.
62 of 62 codes
562694150756269615075626981507562700150720030615052004131506201587150338485815095626621507562664150756266515075626661507562667150756266815075626691507562670150756267115075626721507562673150756267415075626751507562676150756267715075626791507562680150756268115075626821507562683150756268415075626851507562686150756268715075626881507562689150756269015075626911507562692150756269315075626951507562697150756270115075627021507562703150756270415075627051507562706150756270715075627081507562709150756271015075627111507562712150756271315075627141507562715150756271615075627171507562718150756271915075627201507
- Serial No.
- Amount recalled
- 84 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
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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