BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACO PLUS

    MDR report key: 21505 · Received April 27, 1995

    Report

    Report Number
    MW1005747
    Event Type
    Injury
    Date Received
    April 27, 1995
    Date of Event
    February 1, 1995
    Report Date
    March 21, 1995
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHACO MACHINE WAS PRIMED; ONCE PRIMED ORIGINAL SETTINGS ARE USUALLY LOW VACUUM. IT WAS NOT DOUBLE CHECKED, AS INITIAL SCULPTING WAS PERFORMED, THE SURGEON NOTICED A PIECE OF IRIS PULLED INTO PHACO AND ASKED FOR READING OF SETTINGS. IT WAS THEN NOTED THE HIGH VACUUM SETTING WAS LIGHTED ON THE PANEL. COMPUTER BOARD ON MACHINE REPLACED ON 3/1/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO PLUS PHACOEMULSIFICATION UNIT HQC ALLERGAN MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention