Device product
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Z-0631-2013
Product summary
- Event
- Event 63719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 246
- Official record key
device-enforcement:Z-0631-2013
Official wording
Reason: The lenses exceeded the acceptance limit for silicone oil residual.
Code information: 10447500016006, 10519550007006, 10537500016014
Distribution pattern: US Nationwide, including Puerto Rico, and Canada.
Derived failure modes
-
Unknown
The lenses exceeded the acceptance limit for silicone oil residual.