BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3193103 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01261
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE SYSTEM DISPLAYED A SYSTEM MESSAGE DURING THE CUTTING OF THE VITREOUS BODY IN A RETINA PROCEDURE. THE ASPIRATION WAS STOPPED AND THE FUNCTION COULD NOT BE USED. THE MACHINE WAS REBOOTED AND THE OPERATION WAS RESTARTED. A WATER LEAKAGE WAS FOUND AFTER THE SURGERY AND THE CASSETTE INSERTION PART OF MACHINE SIDE WAS WET. THERE WAS NO THREE WAY STOP COCK AND ADAPTER FOUND IN THIS PAK. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS EXPECTED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287871 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 G TOTAL PLUS PAK