BEUDAMED
    FDA Enforcement Class II Terminated

    LAUREATE World Phaco System

    Recall: Z-2834-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2834-2016
    Event ID
    74825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    July 28, 2016
    Classification Date
    September 15, 2016
    Termination Date
    June 7, 2017
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    Description

    LAUREATE World Phaco System

    Reason

    Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)

    Code Info

    Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H

    Distribution

    Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.

    Quantity

    8,646 UNITS