BEUDAMED
    FDA Enforcement Class II Terminated

    Soft Contact Lens

    Recall: Z-0529-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0529-2015
    Event ID
    69496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cooper Vision Caribbean Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    October 28, 2014
    Classification Date
    December 9, 2014
    Termination Date
    October 2, 2015
    Address
    500 Road 584, Amuelas Industrial Park, Juana Diaz, PR, 00795, United States

    Description

    Soft Contact Lens

    Reason

    Portions of the lots may contain units with an incorrect lens axis condition.

    Code Info

    Lots # 8246525202 & 8255525096

    Distribution

    US Nationwide Distribution.

    Quantity

    1170