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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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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.

Product Detail

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