BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATARACT IMPLANT

    MDR report key: 23390321 · Received October 27, 2025

    Report

    Report Number
    MW5177976
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE INSERTION OF THE CATARACT THE LENS WAS CUT. THE MD REQUESTED FOR ANOTHER LENS TO BE PLACED AND AGAIN THE LENS WAS CUT. MD NOTICED A FAULTY POINT TO THE INSERTION SIDE RESULTING IN THE CUT OF THE LENS. A NEW LENS HAD TO BE RETRIEVED FROM A DIFFERENT FACILITY. CASE WAS COMPLETED WITH NO PATIENT HARM. PT CODE: 4580. DEVICE CODE: 1506. REF REPORT: MW5177975.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352449 CATARACT IMPLANT INTRAOCULAR LENS HQL ALCON RESEARCH, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other