BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUET

    MDR report key: 481954 · Received September 2, 2003

    Report

    Report Number
    3019924-2003-00001
    Event Type
    Other
    Date Received
    September 2, 2003
    Date of Event
    August 13, 2003
    Report Date
    August 25, 2003
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR PERFORMED TEN CATARACT SURGERIES. WHILE REMOVING THE LAST LITTLE BITS OF CATARACT FROM TWO DIFFERENT PTS THE ANTERIOR CAPSULE WAS DRAWN INTO THE ASPIRATION PORT AND BECOME DAMAGED OR RUPTURED. THE DOCTOR EXPLAINED THAT HE HAD USED THREE SETS OF INSTRUMENTS AND THAT TWO DIFFERENT ASPIRATION TIPS WERE USED ON THESE TWO DIFFERENT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET 20 GAUGE CURVED ASPIRATION CAPSULE POLISHER HQC MICROSURGICAL TECHNOLOGY, INC. DU-02302 016455

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention PHACOEMULSIFICATION MACHINE, 2003.