FDA Device recall Z-2283-2014
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-2283-2014 |
| 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: 21.5-22.5 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 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310…Serial Num 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310 1002041310 1002051310 1002061310 1002071310 1002081310 1002091310 1002101310 1002111310 1002121310 1002131310 1002141310 1002151310 1002161310 1002171310 1002181310 1002191310 1002201310 1002221310 1002241310 1002281310 1002301310 1002321310 1002341310 1002361310 1002381310 1002391310 1002411310 1002431310 1002451310 1002471310 1002491310 1002511310 1002531310 1002551310 1002571310 1002591310 1002611310 1002621310 1002631310 1002641310 1002651310 1002661310 1002671310 1002681310 1002691310 1002701310 1002711310 1002721310 1002731310 1002741310 1002751310 1002761310 1002771310 1002781310 1002791310 1002801310 1002811310 1002821310 1002831310 1002841310 1002851310 1002861310 1002871310 1002881310 1002891310 1002901310 1002911310 1002921310 1002931310 1002941310 1002951310 1002961310 1002971310 1002 |
|---|
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-2283-2014%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.