FDA Device recall Z-2280-2014
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-2280-2014 |
| 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: 18.5-19.0 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 | 1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312…1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312 1001241312 1001251312 1001261312 1001271312 1001291312 1001301312 1001311312 1001321312 1001331312 1001341312 1001351312 1001361312 1001371312 1001381312 1001391312 1001401312 1001411312 1001421312 1001431312 1001441312 1001451312 1001461312 1001471312 1001481312 1001491312 1001501312 1001511312 1001521312 1001531312 1001541312 1001551312 1001571312 1001591312 1001611312 1001631312 1001651312 1001671312 1001691312 1001711312 1001731312 1001751312 1001771312 1001811312 1001831312 1001851312 1001871312 1001891312 1001911312 1001931312 1001951312 1001971312 1001991312 1002001312 1002021312 1002041312 1002061312 1002081312 1002101312 1002121312 1002131312 1002141312 1002151312 1002161312 1002171312 1002181312 1002201312 1002221312 1002231312 1005251309 1005261309 1005271309 1005281309 1005291309 1005 |
|---|
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-2280-2014%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.