FDA Device recall Z-2285-2014
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-2285-2014 |
| 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: 24.5, 25, 25.5 & 26. 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 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311…Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311 1004991311 1005001311 1005021311 1005041311 1005061311 1005071311 1005091311 1005111311 1005121311 1005151311 1005161311 1005171311 1005181311 1005191311 1005201311 1005211311 1005221311 1005231311 1005241311 1005251311 1005291311 1005331311 1005351311 1005521311 1005531311 1005541311 1005551311 1005561311 1005571311 1005591311 1005611311 1005651311 1005711311 1005731311 1005751311 1005771311 1005791311 1005811311 1005831311 1005841311 1005851311 1014291310 1014301310 1014311310 1014411310 1014421310 1014431310 1014451310 1014511310 1014521310 1014531310 1014541310 1014561310 1014581310 1014591310 1014601310 1014611310 1014641310 1014661310 1014671310 1014701310 1014721310 1014 |
|---|
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-2285-2014%22
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