FDA Device recall Z-2274-2014
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-2274-2014 |
| 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: 12.0 and 12.5 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 | 1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871…1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871311 1036351309 1190491309 1191431309 1221481309 1016891311 1036371309 1190501309 1191441309 1221491309 1016911311 1036381309 1190511309 1191461309 1221501309 1016931311 1036401309 1190521309 1191471309 1221521309 1016951311 1036421309 1190531309 1191481309 1221531309 1016971311 1036431309 1190541309 1220991309 1221541309 1016991311 1036451309 1190551309 1221011309 1221551309 1017011311 1036461309 1190561309 1221021309 1221561309 1017031311 1036471309 1190571309 1221031309 1221571309 1017051311 1036491309 1190581309 1221041309 1221581309 1017071311 1036511309 1190591309 1221051309 1221591309 1017091311 1036521309 1190601309 1221061309 1221601309 1017111311 1036531309 1190611309 1221071309 1221611309 1017131311 1036541309 1190621309 1221081309 1221621309 1017151311 1036561309 1190631309 1221091309 1221631309 1017171311 1036581309 1190641309 1221111309 1221 |
|---|
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-2274-2014%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.