BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON PHACO UNIT

    MDR report key: 36408 · Received July 2, 1996

    Report

    Report Number
    36408
    Event Type
    Malfunction
    Date Received
    July 2, 1996
    Date of Event
    April 23, 1996
    Report Date
    May 1, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE TUNING PROCEDURE FOR THE HAND PIECE, THE UNIT BECAME INOPERATIVE. IT DISPLAYED 5 VOLT FAILURE. A DIFFERENT SURGICAL PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON PHACO UNIT PHACO UNIT HQC ALCON LABORATORIES 5TTM-AH *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other