FDA Device recall Z-2286-2014
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-2286-2014 |
| 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: 26.5, 27, 27.5 & 28.5. 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 | Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309…Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309 1007571309 1007581309 1007591309 1007601309 1007611309 1007621309 1007631309 1007641309 1007651309 1007661309 1007671309 1007681309 1007691309 1007701309 1007711309 1007721309 1007731309 1007741309 1007751309 1007761309 1007771309 1007791309 1007801309 1007811309 1007821309 1007831309 1007841309 1007851309 1007861309 1007871309 1007881309 1007891309 1007901309 1007911309 1007921309 1007931309 1007941309 1007951309 1007961309 1007971309 1007981309 1007991309 1008001309 1008011309 1008021309 1008031309 1008041309 1008051309 1008061309 1008101309 1008121309 1008141309 1008161309 1008171309 1008181309 1008191309 1008201309 1008211309 1008221309 1008231309 1008241309 1008251309 1008 |
|---|
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-2286-2014%22
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