BEUDAMED
    FDA Enforcement Class II Terminated

    Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)

    Recall: Z-1227-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1227-2020
    Event ID
    84725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperVision Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 13, 2020
    Classification Date
    February 13, 2020
    Termination Date
    July 22, 2020
    Address
    180 Thruway Park Dr, West Henrietta, NY, 14586-9798, United States

    Description

    Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)

    Reason

    Incorrect power of lenses than the expected

    Code Info

    Lot Numbers: 15627000009010 15627050004010 16656000008010

    Distribution

    US Nationwide Distribution

    Quantity

    216 units