BEUDAMED
    FDA Enforcement Class II Ongoing

    Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.

    Recall: Z-2607-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2607-2025
    Event ID
    97515
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperVision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 1, 2025
    Initiation Date
    August 22, 2025
    Classification Date
    September 19, 2025
    Address
    180 Thruway Park Dr, N/A, West Henrietta, NY, 14586-9798, United States

    Description

    Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.

    Reason

    One lot manufactured with an invalid sterilization cycle.

    Code Info

    Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898

    Distribution

    US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.

    Quantity

    180 units