BEUDAMED
    FDA Recall Terminated

    ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.

    Recall: Z-0134-2015 · Initiated September 17, 2014

    Recall

    Recall Number
    Z-0134-2015
    Event Number
    69160
    Firm
    Cooper Vision Caribbean Corp. #
    FEI Number
    3002911336
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 17, 2014
    Posted
    October 24, 2014
    Terminated
    June 10, 2015
    Address
    500 Road 584, Amuelas Industrial Park Juana Diaz, PR, 00795

    Description

    ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.

    Reason

    Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

    Action

    The firm sent out a notification letter with the following instructions: Please take the following actions immediately: " Examine your inventory for any affected lot numbers o Use the enclosed report to inspect your inventory for affected product that is still in your Warehouse. " Stop any further distribution of the specified lots of Preclear T oric lenses. " Quarantine any Preclear Toric lenses with the specified lot numbers. " Within the next five (5) business days, please complete the attached Recall Response Form and fax it to 866-484-1048 or scan and email to [email protected]. o If you have indicated that you have product to return, you will be contacted by a CooperVision Representative with instructions for pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. This action is being taken in full cooperation with the Food and Drug Administration (FDA). The recall only affects Proclear T oric lenses with the lot numbers specified on the enclosed list. No other Preclear T oric products- or any other CooperVision products - are affected.

    Distribution

    Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.

    Quantity

    13639 lenses/246 product lots