FDA Device recall Z-2281-2014
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-2281-2014 |
| 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: 19.5-20 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 | Serial Num 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311…Serial Num 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311 1014711311 1014721311 1014731311 1014741311 1014751311 1014761311 1014771311 1014781311 1014791311 1014801311 1014811311 1014821311 1014831311 1014841311 1014851311 1014861311 1014871311 1014881311 1014891311 1014901311 1014911311 1014921311 1014931311 1014941311 1014951311 1014961311 1014971311 1014981311 1014991311 1015001311 1015011311 1015021311 1015031311 1015041311 1015051311 1015061311 1015071311 1015081311 1015091311 1015101311 1015111311 1015121311 1015131311 1015141311 1015151311 1015161311 1015171311 1015181311 1015191311 1015201311 1015211311 1015221311 1015231311 1015241311 1015251311 1015261311 1015271311 1015281311 1015291311 1015301311 1015311311 1015321311 1015331311 1015341311 1015351311 1015361311 1015371311 1015381311 1015391311 1015401311 1015411311 1015421311 1015431311 1015 |
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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-2281-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.