BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

    Recall: Z-0978-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0978-2017
    Event ID
    75049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    September 5, 2016
    Classification Date
    January 9, 2017
    Termination Date
    February 10, 2017
    Address
    6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

    Reason

    The intraocular lens could become lodged within the cartridge

    Code Info

    Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015

    Distribution

    Distributed to Mexico only

    Quantity

    1,130 units