Reported Aug 27, 2014 · Terminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the…
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. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13
- mm with the following diopter sizes
15.516.0
- Product UsageAMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag
- Lot codes and dates
1,922 of 1,922 codes
101436130910148513091022981309102350130910239713091097131310112480131011253113101014371309101486130910230013091023511309102398130910971413101124811310112533131010143813091014871309102301130910235213091023991309109716131011248213101125351310101439130910148813091023021309102353130910240113091097181310112483131011253613101014401309101489130910230313091023541309102403130910972013101124841310112537131010144113091014901309102304130910235513091096541310109722131011248513101125381310101442130910149113091023051309102356130910965613101097241310112486131011253913101014431309101492130910230613091023571309
- Amount recalled
- 77,055 IOLs in total
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Units may be labeled with the incorrect diopter power.
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.
Free recall alerts
Get alerted about new AMO Puerto Rico Manufacturing, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.