BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2802966 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01636
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 21, 2012
    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
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE IRRIGATION STOPPED WHEN SWITCHING FROM CORE VITRECTOMY MODE TO THE SHAVING MODE. THE INFUSION LINE WAS SWITCHED OUT TWICE, BUT THE PROBLEM PERSISTED. WHEN TRYING TO SWITCH TO FLUID/AIR EXCHANGE (F/AX) THE SYSTEM STOPPED WORKING FOR FIVE MINUTES THEN BEGAN WORKING AGAIN. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1