BEUDAMED
    FDA Enforcement Class III Ongoing

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    Recall: Z-2451-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2451-2025
    Event ID
    97232
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bausch & Lomb Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    June 6, 2025
    Classification Date
    August 26, 2025
    Address
    21 N Park Place Blvd, Clearwater, FL, 33759-3917, United States

    Description

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    Reason

    An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.

    Code Info

    UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010

    Distribution

    US: AZ, CA

    Quantity

    2