FDA Device recall Z-2277-2014
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002 by Amo Puerto Rico Manufacturing, citing units may be labeled with the incorrect diopter power.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-13 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Amo Puerto Rico Manufacturing |
| Distribution | US |
Product
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: 15.5, 16.0 Product Usage: AMO 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.
Reason
Units may be labeled with the incorrect diopter power.
Identifiers
| code_info | 1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 10230013…1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 1023001309 1023511309 1023981309 1097141310 1124811310 1125331310 1014381309 1014871309 1023011309 1023521309 1023991309 1097161310 1124821310 1125351310 1014391309 1014881309 1023021309 1023531309 1024011309 1097181310 1124831310 1125361310 1014401309 1014891309 1023031309 1023541309 1024031309 1097201310 1124841310 1125371310 1014411309 1014901309 1023041309 1023551309 1096541310 1097221310 1124851310 1125381310 1014421309 1014911309 1023051309 1023561309 1096561310 1097241310 1124861310 1125391310 1014431309 1014921309 1023061309 1023571309 1096581310 1097251310 1124871310 1125401310 1014441309 1014931309 1023071309 1023581309 1096591310 1097261310 1124881310 1125411310 1014451309 1014941309 1023081309 1023591309 1096601310 1097271310 1124891310 1125421310 1014461309 1014951309 1023111309 1023601309 1096611310 1097281310 1124901310 1125431310 1014471309 1014961309 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2014%22
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