BEUDAMED
    FDA Enforcement Class II Ongoing

    Biofinity XR Toric Contact Lens

    Recall: Z-2165-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2165-2025
    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 XR Toric Contact Lens

    Reason

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

    Code Info

    Carton Lot Numbers: RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123, RD0228336, RD0228465, RD0228570, RD0228595, RD0228598, RD0228603, RD0228606, RD0228607, RD0228775, RD0228778, RD0228788, RD0228795, RD0228798, RD0228799, RD0228802, RD0228809, RD0228814, RD0228825, RD0228835, RD0228840, RD0228842, RD0228847, RD0228853, RD0228854, RD0228855, RD0228866, RD0228875, RD0228876, RD0228940, RE0152731, RE0152735, RE0152737, RE0152740, RE0152743, RE0152744, RE0152755, RE0152760, RE0152775, RE0152799, RE0152838, RE0152871, RE0152873, RE0152877, RE0152883, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329.

    Distribution

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

    Quantity

    397 units