BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY & ACCESSORIES

    MDR report key: 46897 · Received November 1, 1996

    Report

    Report Number
    2028159-1996-00192
    Event Type
    Malfunction
    Date Received
    November 1, 1996
    Report Date
    October 3, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT METAL PARTICLES (FLAKES ON IRIS) WERE NOTED ONE WEEK POST OP. USES 2 INSTRUMENT TECHNIQUE BUT DOES NOT THINK THAT IS A FACTOR. NO INJURY AND NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY & ACCESSORIES OPHTHALMIC SURGERY SYSTEM-HANDPIECE HQE ALCON LABORATORIES, INC. STTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO