BEUDAMED
    FDA Recall Open, Classified

    Constellation Vision System, REF: 8065751150

    Recall: Z-0099-2024 · Initiated August 18, 2023

    Recall

    Recall Number
    Z-0099-2024
    Event Number
    93010
    Firm
    Alcon Research, LLC
    FEI Number
    1000125771
    Product Code
    HQC
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    August 18, 2023
    Posted
    October 11, 2023
    Address
    15800 Alton Pkwy, Irvine, CA, 92618-3818

    Description

    Constellation Vision System, REF: 8065751150

    Reason

    Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

    Action

    Starting on 8/18/23, Field Service Engineers told customers their devices needed pneumatics module replacements, and this replacement activity was subsequently completed. On 9/29/23, correction notices were mailed to customers informing them vision systems were corrected and asking they complete and return the response form to [email protected] Should you have any questions or concerns call Customer Service at 1-800-862-5266.

    Distribution

    US: GA, IL, PR

    Quantity

    3