BEUDAMED
    FDA Recall Terminated

    LAUREATE World Phaco System

    Recall: Z-2834-2016 · Initiated July 28, 2016

    Recall

    Recall Number
    Z-2834-2016
    Event Number
    74825
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 28, 2016
    Posted
    September 15, 2016
    Terminated
    June 7, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    LAUREATE World Phaco System

    Reason

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

    Action

    All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments.

    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