Z-0631-2013 Class II Terminated
FDA device recall Z-0631-2013 was initiated by Cooper Vision Caribbean Corp. on November 9, 2012 and is designated Class II. Reason for recall: The lenses exceeded the acceptance limit for silicone oil residual. The recall status is terminated (terminated May 9, 2014). Affected quantity: 246.
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2013
- Initiation Date
- November 9, 2012
- Termination Date
- May 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 246
Product Description
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Reason for Recall
The lenses exceeded the acceptance limit for silicone oil residual.
Distribution Pattern
US Nationwide, including Puerto Rico, and Canada.
Code Information
10447500016006, 10519550007006, 10537500016014