Reported Mar 12, 2014 · Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for…
AMO Puerto Rico Manufacturing, 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: AMO Puerto Rico Manufacturing, Inc. · Rd # 402, Km 4.2 · Anasco, PR · 00610
Is this the product you have?
- AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
- diopter size16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients
- Lot codes and dates
169 of 169 codes
100000131010006013101230911309123121130912315113091231811309100001131010003113101000611310123092130912312213091231521309123182130910000213101000321310100062131012309313091231231309123153130912318313091000031310100033131010006313101230941309123124130912315413091231841309100004131010003413101000641310123095130912312513091231551309100005131010003513101000651310123096130912312613091231561309100006131010003613101000661310123097130912312713091231571309100007131010003713101000671310123098130912312813091231581309100008131010003813101000681310123099130912312913091231591309100009131010003913101000691310
- Amount recalled
- 169 units
Where it was sold
- Nationwide
Why it was recalled
Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
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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