BEUDAMED
    FDA Enforcement Class II Ongoing

    Biofinity Toric Multifocal Contact Lens

    Recall: Z-2166-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2166-2025
    Event ID
    97173
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperVision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    June 16, 2025
    Classification Date
    July 23, 2025
    Address
    711 North Rd, N/A, Scottsville, NY, 14546-1238, United States

    Description

    Biofinity Toric Multifocal Contact Lens

    Reason

    Lens blisters may have an incomplete or leaking seal which may render them unsterile.

    Code Info

    Carton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967

    Distribution

    Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

    Quantity

    827 units