BEUDAMED
    FDA Enforcement Class II Terminated

    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

    Recall: Z-0631-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0631-2013
    Event ID
    63719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Vision Caribbean Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 9, 2013
    Initiation Date
    November 9, 2012
    Classification Date
    January 3, 2013
    Termination Date
    May 9, 2014
    Address
    #500 Road 584, Amuelas Industrial Park, Juana Diaz, PR, 00795, United States

    Description

    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

    Reason

    The lenses exceeded the acceptance limit for silicone oil residual.

    Code Info

    10447500016006, 10519550007006, 10537500016014

    Distribution

    US Nationwide, including Puerto Rico, and Canada.

    Quantity

    246