FDA Device recall Z-2287-2014
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-2287-2014 |
| 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: 29, 29.5 & 30. 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 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309…Serial Num 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309 1102221309 1102231309 1102241309 1102261309 1102271309 1102291309 1102301309 1102311309 1102321309 1102331309 1102351309 1102371309 1102381309 1102391309 1102401309 1102411309 1102431309 1102461309 1102481309 1102501309 1102551309 1102621309 1102641309 1102651309 1102661309 1102681309 1102811309 1102831309 1102851309 1102871309 1102911309 1102941309 1289831308 1289841308 1289851308 1289861308 1289871308 1289881308 1289891308 1289901308 1289911308 1289921308 1289931308 1289941308 1289961308 1290001308 1290021308 1290041308 1290061308 1290071308 1290081308 1290091308 1290101308 1290111308 1290121308 1290141308 1290161308 1290171308 1290181308 1290191308 1290201308 1290211308 1290 |
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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-2287-2014%22
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