FDA Device recall Z-2272-2014
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-2272-2014 |
| 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: 10.0 and 10.5 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 | 1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 104278…1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309 1004501311 1042861309 1166871309 1004521311 1042881309 1166881309 1004561311 1042901309 1166891309 1004581311 1042941309 1166901309 1004601311 1042961309 1166911309 1004621311 1043061309 1166921309 1004631311 1043081309 1166941309 1004641311 1043121309 1166961309 1004661311 1043141309 1166971309 1004671311 1043161309 1166981309 1004681311 1166391309 1166991309 1042091309 1166431309 1167001309 1042111309 1166441309 1167021309 1042191309 1166451309 1167041309 1042271309 1166471309 1167051309 1042291309 1166481309 1167061309 1042311309 1166511309 1167081309 1042331309 1166531309 1167101309 1042351309 1166561309 1167111309 1042391309 1166581309 1167131309 1042481309 1166601309 1167141309 1042571309 1166621309 1167151309 1042581309 116 |
|---|
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-2272-2014%22
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