FDA Device recall Z-2278-2014
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-2278-2014 |
| 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: 16.5, 17.0 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 | 1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 10318213…1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309 1031881311 1032441311 1041231312 1041771312 1042221312 1048421311 1006381309 1006961309 1031891311 1032461311 1041241312 1041781312 1042231312 1048441311 1006391309 1006981309 1031901311 1032481311 1041251312 1041791312 1042241312 1048461311 1006401309 1007001309 1031911311 1032501311 1041261312 1041801312 1042251312 1048481311 1006411309 1007021309 1031921311 1032521311 1041271312 1041811312 1047821311 1048501311 1006421309 1007031309 |
|---|
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-2278-2014%22
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