BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON PANOPTIX CLAREON TORIC LENS

    MDR report key: 17827716 · Received September 26, 2023

    Report

    Report Number
    MW5146214
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 22, 2023
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTRAOCULAR LENS IMPLANT WAS INSERTED INTO PATIENT'S EYE DURING UNCOMPLICATED CATARACT SURGERY. UPON INSERTION, SMALL METALLIC APPEARING PARTICLE WAS NOTED IN THE LENS IMPLANT, ADJACENT TO THE "TORIC" MARKS ON THE LENS. DUE TO THE PARTICLE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416902 ALCON PANOPTIX CLAREON TORIC LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LLC. IOL PANOPTIX TORIC UV ABSORB CC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other