BEUDAMED
    FDA Enforcement Class II Terminated

    Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

    Recall: Z-1062-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-1062-2014
    Event ID
    67283
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 26, 2014
    Initiation Date
    October 16, 2013
    Classification Date
    February 20, 2014
    Termination Date
    September 17, 2014
    Address
    21 N Park Place Blvd, Clearwater, FL, 33759-3917, United States

    Description

    Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

    Reason

    Lens was manufactured with incorrect raw material.

    Code Info

    Model Numbers(s): AO60 and MI60L

    Distribution

    Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.

    Quantity

    336 IOLs (283 IOLs in the US, 53 IOLs outside the US)