FDA Device recall Z-2282-2014
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-2282-2014 |
| 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: 20.5-21 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 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311…Serial Num 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311 1000721311 1000741311 1000761311 1000781311 1000801311 1000821311 1000841311 1000861311 1000881311 1000891311 1000901311 1000911311 1000921311 1000931311 1000941311 1000951311 1000961311 1000971311 1000981311 1000991311 1001001311 1001011311 1001021311 1001031311 1001041311 1001051311 1001061311 1001071311 1001081311 1001091311 1001101311 1001111311 1001121311 1001131311 1001141311 1001151311 1001161311 1001171311 1001181311 1001191311 1001201311 1001211309 1001211311 1001221311 1001231309 1001231311 1001241311 1001251309 1001251311 1001261311 1001271309 1001271311 1001281311 1001291309 1001291311 1001301311 1001311309 1001311311 1001321311 1001331311 1001341311 1001351311 1001361311 1001371311 1001381311 1001391311 1001401309 1001401311 1001411309 1001411311 1001421311 1001431309 1001431311 1001 |
|---|
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-2282-2014%22
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