AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design — Class II medical device recall Z-2280-2014
Terminated recall by AMO Puerto Rico Manufacturing, Inc., reported 2014-08-27, distributed nationwide. Units may be labeled with the incorrect diopter power.
| Recall number | Z-2280-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMO Puerto Rico Manufacturing, Inc., Anasco, PR, United States |
| Recall initiated | 2014-05-13 |
| Classified | 2014-08-19 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2017-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 77,055 iols |
| Reason classes | labeling |
| Model numbers | Z9002 |
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 for recall
Units may be labeled with the incorrect diopter power.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2280-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.