BEUDAMED
    FDA Recall Terminated

    eye-pak 7407 Tray Support Cover REF 8065740745

    Recall: Z-2694-2014 · Initiated June 3, 2014

    Recall

    Recall Number
    Z-2694-2014
    Event Number
    68487
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HMT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 3, 2014
    Posted
    September 24, 2014
    Terminated
    July 27, 2015
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    eye-pak 7407 Tray Support Cover REF 8065740745

    Reason

    The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

    Action

    Alcon Research sent an Urgent Medical Device Recall letter dated June 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please follow these important steps: 1) Review your inventory of Tray Support Covers to determine if you have any units from the affected Lots in stock. 2) Place the product aside to ensure it is not used. 3) Return the attached Response Form via fax or email to Alcon. Please return the Response Form even if you do not have any inventory from the affected lots. 4) Alcon will contact you to arrange the return of your inventory. If you have any further questions, concerns, or need assistance with obtaining replacement product, please contact Alcon Customer Service at 1-800-862-5266.

    Distribution

    Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.

    Quantity

    2462