FDA Device recall Z-2279-2014
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-2279-2014 |
| 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: 17.5, 18.0 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 | 1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 10125213…1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 1012521311 1013101311 1027661310 1028141310 1031871309 1032401309 1004291312 1004851312 1012541311 1013121311 1027671310 1028151310 1031881309 1032411309 1004301312 1004861312 1012601311 1013141311 1027691310 1028161310 1031891309 1032421309 1004311312 1004871312 1012621311 1013161311 1027701310 1028171310 1031901309 1032431309 1004321312 1004881312 1012641311 1013181311 1027711310 1028181310 1031921309 1032441309 1004331312 1004891312 1012661311 1013201311 1027721310 1028191310 1031941309 1032451309 1004341312 1004901312 1012681311 1013221311 1027731310 1028201310 1031951309 1032461309 1004351312 1004911312 1012701311 1013241311 1027741310 1028211310 1031961309 1032471309 1004361312 1004921312 1012711311 1013261311 1027751310 1028221310 1031981309 1032481309 1004371312 1004931312 1012721311 1013281311 1027761310 1028231310 1032001309 1032491309 1004381312 1004941312 |
|---|
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-2279-2014%22
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