BEUDAMED
    FDA Recall Terminated

    Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)

    Recall: Z-1228-2020 · Initiated January 13, 2020

    Recall

    Recall Number
    Z-1228-2020
    Event Number
    84725
    Firm
    CooperVision Inc.
    FEI Number
    3005724763
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 13, 2020
    Posted
    January 27, 2020
    Terminated
    July 22, 2020
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798

    Description

    Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)

    Reason

    Incorrect power of lenses than the expected

    Action

    CooperVision issued Device Correction letter dated 1/20/19, stating reason for recall, health risk and action to take: Examine your inventory for the impacted lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of Vertex Toric and 2 Clear Toric lenses as appropriate. " Please discard product and contact CooperVision, Customer Service department at 1-800-340-2020 to receive credit and/or complimentary replacement product. Questions contact CooperVision Customer Service at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.

    Distribution

    US Nationwide Distribution

    Quantity

    24