FDA Recall
Terminated
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Recall: Z-0631-2013
·
Initiated November 9, 2012
Recall
- Recall Number
- Z-0631-2013
- Event Number
- 63719
- Firm
- Cooper Vision Caribbean Corp. #
- FEI Number
- 3002911336
- Product Code
- LPL
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- November 9, 2012
- Posted
- January 3, 2013
- Terminated
- May 9, 2014
- Address
- 500 Road 584, Amuelas Industrial Park Juana Diaz, PR, 00795
Description
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Reason
The lenses exceeded the acceptance limit for silicone oil residual.
Action
The recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.
Distribution
US Nationwide, including Puerto Rico, and Canada.
Quantity
246