BEUDAMED
    FDA Recall Terminated

    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.

    Recall: Z-1702-2015 · Initiated April 28, 2015

    Recall

    Recall Number
    Z-1702-2015
    Event Number
    71156
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 28, 2015
    Posted
    June 9, 2015
    Terminated
    March 24, 2016
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.

    Reason

    The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.

    Action

    Alcon sent a Recall letter dated April 28, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a return form and instructions for credit. Customers were instructed to review inventory for any affected units, segregat the product to ensure it is not used, and return the attached Response Form via fax or email to Alcon. For questions or need assistance with obtaining replacement products contact Alson Customer service at 800-862-5266.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Australia and Canada.

    Quantity

    219,680 units