FDA Device recall Z-2275-2014
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-2275-2014 |
| 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: 13.0, 13.5, 14.0 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 | 1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 11129913…1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310 1214401310 1262721310 1290531308 1030831310 1031351310 1113031309 1113561309 1213891310 1214421310 1262731310 1290541308 1030841310 1031361310 1113051309 1113571309 1213911310 1214441310 1262751310 1290551308 1030861310 1031371310 1113071309 1113581309 1213921310 1214461310 1262771310 1290561308 1030871310 1031381310 1113091309 1113601309 1213941310 1214481310 1262781310 1290571308 1030881310 1031391310 1113101309 1113621309 1213951310 1214491310 1262791310 1290581308 1030891310 1031401310 1113111309 1113661309 1213961310 1214501310 1262801310 1290591308 1030901310 1031411310 1113121309 1113681309 1213971310 1214511310 1262811310 1290601308 1030911310 1031421310 1113131309 1113701309 1213981310 1214521310 1262821310 1290611308 1030921310 1031431310 |
|---|
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-2275-2014%22
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