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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
AVAIRA Soft Contact Lenses		see related information
Date Posted January 03, 2013
Recall Number Z-0631-2013
Product AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Code Information 10447500016006, 10519550007006, 10537500016014
Recalling Firm/
Manufacturer		 Cooper Vision Caribbean Corp.
#500 Road 584
Amuelas Industrial Park
Juana Diaz, Puerto Rico 00795
Reason for
Recall		 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.
Quantity in Commerce 246
Distribution US Nationwide, including Puerto Rico, and Canada.
 
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