BEUDAMED
    FDA Recall 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 · Initiated July 25, 2018

    Recall

    Recall Number
    Z-1794-2020
    Event Number
    85198
    Firm
    Alcon Research LLC
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 25, 2018
    Terminated
    April 24, 2020
    Address
    6201 South Fwy Aspex Facility Fort, Worth, TX, 76134-2099

    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.

    Action

    The firm issued undated letters to the foreign consignees on 7/25/2018 advising them of the issue and to return affected product.

    Distribution

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

    Quantity

    102 packs