BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACO MACHINE

    MDR report key: 21743 · Received May 10, 1995

    Report

    Report Number
    MW1005883
    Event Type
    Malfunction
    Date Received
    May 10, 1995
    Date of Event
    April 13, 1995
    Report Date
    May 2, 1995
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE I/A MODE (IRRIGATION/ASPIRATION) OF THE PHACOEMULSIFIER MALFUNCTIONED. MODE WOULD NOT TURN ON NOR WOULD IT STAY ON. MACHINE WOULD REVERT BACK TO CAUTERY. MACHINE TESTED BY BIOMED DEPT FOUND I/A MODE INOPERATIVE DUE TO AN INTERNAL COMPONENT FAILURE. FURTHER TESTING CONTINUES. NO ADVERSE OUTCOME DURING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO MACHINE PHACOEMULSIFIER HQC ALLERGAN MEDICAL OPTICS 6000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other