FDA Device recall Z-2284-2014
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-2284-2014 |
| 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: 23, 23.5 & 24. 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 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310…Serial Num 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310 1006351310 1006371310 1006371312 1006391310 1006391312 1006411310 1006411312 1006431310 1006431312 1006451310 1006451312 1006471310 1006471312 1006481310 1006491310 1006491312 1006501310 1006511310 1006511312 1006521310 1006531310 1006531312 1006541310 1006551310 1006561310 1006571310 1006591310 1006601310 1006611310 1006621310 1006631310 1006641310 1006651310 1006661310 1006671310 1006681310 1006691310 1006701310 1006711310 1006721310 1006731310 1006741310 1006751310 1006761310 1006771310 1006781310 1006791310 1006801310 1006811310 1006821310 1006831310 1006841310 1006851310 1006871310 1006881310 1006891310 1006901310 1006911310 1006921310 1006931310 1006931312 1006941310 1006951310 1006951312 1006961310 1006971310 1006981310 1007001310 1007221312 1007241312 1007261312 1007281312 1007301312 1007 |
|---|
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-2284-2014%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.