BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON LEGACY

    MDR report key: 50174 · Received November 15, 1996

    Report

    Report Number
    50174
    Event Type
    Other
    Date Received
    November 15, 1996
    Date of Event
    October 16, 1996
    Report Date
    October 27, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT, TRABECULECTOMY RIGHT EYE. THE SURGEON NEEDED TO PERFORM A VITRECTOMY. THE MACHINE WAS NOT WORKING TO THE SURGEON'S EXPECTATIONS. THE SURGEON FELT THE MACHINE DID NOT HAVE ENOUGH SUCTION. AFTER SOME PERIOD OF TIME, A NURSE OBSERVED THE MACHINE WAS ON PANEL CONTROL AND WHEN PLACED ON SURGEON CONTROL, THE MACHINE WORKED PROPERLY. HOSP WAS INFORMED DURING POST-OP PHONE CALL THAT THE PT HAS NO VISION IN RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LEGACY PHACO MACHINE HQC ALCON LABORATORIES SERIES 20000STTL *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other 10/16/96