BEUDAMED
    FDA Enforcement Class II Completed

    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    Recall: Z-1821-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1821-2020
    Event ID
    84839
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Allied Vision Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 6, 2020
    Initiation Date
    August 1, 2018
    Classification Date
    April 29, 2020
    Address
    5350 Nw 35th Ave, N/A, Fort Lauderdale, FL, 33309-6314, United States

    Description

    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    Reason

    Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.

    Code Info

    Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.

    Distribution

    Worldwide and US Nationwide

    Quantity

    655 boxes with 6 units per box. total 3930