AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design — Class II medical device recall Z-1123-2014
Terminated recall by AMO Puerto Rico Manufacturing, Inc., reported 2014-03-12, distributed nationwide. Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
| Recall number | Z-1123-2014 |
|---|---|
| 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 | 2014-01-28 |
| Classified | 2014-03-03 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2017-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, JP |
| Quantity | 169 units |
| Reason classes | labeling |
| Model numbers | Z9002 |
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
Reason for recall
Certain Silicone TECNIS IOLs 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-1123-2014. 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.