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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

Product Description AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Recall Number Z-0631-2013
Classification Class II
Code Info 10447500016006, 10519550007006, 10537500016014
Product Distributed Qty 246
Reason For Recall The lenses exceeded the acceptance limit for silicone oil residual.

Event Detail

Event Id 63719
Product Type Devices
Status Ongoing
Recalling Firm Cooper Vision Caribbean Corp.
City Juana Diaz
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Nationwide, including Puerto Rico, and Canada.