FDA Device recall Z-2276-2014
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-2276-2014 |
| 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: 14.5, 15.0 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 | 1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 10251313…1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 1025131309 1025581309 1028511309 1039921310 1040371310 1093811310 1019741311 1020221311 1025141309 1025591309 1028521309 1039931310 1040381310 1093821310 1019751311 1020231311 1025151309 1025601309 1028531309 1039941310 1040391310 1093831310 1019761311 1020241311 1025161309 1025611309 1028541309 1039951310 1040401310 1093841310 1019771311 1020251311 1025171309 1025621309 1028551309 1039961310 1040411310 1093851310 1019781311 1020261311 1025181309 1025631309 1028561309 1039971310 1040421310 1093861310 1019791311 1020271311 1025191309 1025641309 1028571309 1039981310 1040431310 1093871310 1019801311 1020281311 1025201309 1025651309 1028581309 1039991310 1040441310 1093881310 1019811311 1020291311 1025211309 1025661309 1028591309 1040001310 1040451310 1093891310 1019821311 1020301311 1025221309 1025671309 1028601309 1040011310 1040461310 1093911310 1019831311 1020311311 |
|---|
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-2276-2014%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.