FDA Device recall Z-2271-2014
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-2271-2014 |
| 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: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 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 | 1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309…1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309 1039641309 1114081309 1114411309 1114431309 1114621309 1114841309 1114861309 1114871309 1114881309 1114891309 1114921309 1297261308 1297361308 1297411308 1297491308 1297511308 1297561308 1297571308 1297581308 1297601308 1297801308 1169561309 1169601309 1169641309 1169681309 1169691309 1169721309 1169731309 1169761309 1169791309 1169801309 1169831309 1169841309 1169 |
|---|
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-2271-2014%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.