FDA Device recall Z-0631-2013
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
- FDA Device
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses by Cooper Vision Caribbean, citing the lenses exceeded the acceptance limit for silicone oil residual.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0631-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-09 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cooper Vision Caribbean |
| Distribution | US |
Product
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Reason
The lenses exceeded the acceptance limit for silicone oil residual.
Identifiers
| code_info | 10447500016006, 10519550007006, 10537500016014 |
|---|
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-0631-2013%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.