BEUDAMED
    FDA Recall 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 · Initiated September 5, 2016

    Recall

    Recall Number
    Z-0978-2017
    Event Number
    75049
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    MSS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 5, 2016
    Posted
    January 9, 2017
    Terminated
    February 10, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    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

    Action

    Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-3058.

    Distribution

    Distributed to Mexico only

    Quantity

    1,130 units