BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    Recall: Z-1794-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1794-2020
    Event ID
    85198
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    July 25, 2018
    Classification Date
    April 23, 2020
    Termination Date
    April 24, 2020
    Address
    6201 South Fwy, Aspex Facility, Fort Worth, TX, 76134-2099, United States

    Description

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    Reason

    There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.

    Code Info

    Lot #2128524H

    Distribution

    There was no domestic distribution. Foreign distribution was made to Germany, Iraq, Israel, Italy, and Moldova.

    Quantity

    102 packs