FDA Device recall Z-2273-2014
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-2273-2014 |
| 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: 11.0 and 11.5 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 | 1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177…1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309 1229261309 1177621309 1229271309 1177681309 1229281309 1177751309 1229291309 1177771309 1229301309 1177791309 1229311309 1177811309 1229321309 1177821309 1229331309 1177831309 1229341309 1177841309 1229351309 1177861309 1229381309 1177881309 1229401309 1177901309 1229501309 1177921309 1229521309 1178041309 1229541309 1178061309 1229551309 1178081309 1229561309 1178101309 1229571309 1178121309 1229581309 1178141309 1229591309 1178151309 1229601309 1178161309 1229611309 1178181309 1229621309 1178201309 1229631309 1178211309 1229651309 1178221309 1229671309 1228801309 1229681309 1228821309 1229691309 1228851309 1229701309 1228861309 1229721309 1228881309 1229741309 1228901309 1229761309 1228921309 1229771309 1228941309 |
|---|
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-2273-2014%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.