AVAIRA — Class II medical device recall Z-0631-2013
Terminated recall by Cooper Vision Caribbean Corp., reported 2013-01-09, distributed nationwide. The lenses exceeded the acceptance limit for silicone oil residual.
| Recall number | Z-0631-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Vision Caribbean Corp., Juana Diaz, PR, United States |
| Recall initiated | 2012-11-09 |
| Classified | 2013-01-03 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2014-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 246 |
| UPC / GTIN / UDI-DI | 10447500016006 |
Product
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Reason for recall
The lenses exceeded the acceptance limit for silicone oil residual.
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-0631-2013. 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.