BEUDAMED
    FDA Enforcement Class II Terminated

    eye-pak 7407 Tray Support Cover REF 8065740745

    Recall: Z-2694-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2694-2014
    Event ID
    68487
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    June 3, 2014
    Classification Date
    September 24, 2014
    Termination Date
    July 27, 2015
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    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.

    Code Info

    Item Number 8065740745 with Lot numbers 613207-07V, 613221-07V, 613228-07V, 613249-07V, 613256-07V, 35206V, and 352699V.

    Distribution

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

    Quantity

    2462