BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3102338 · Received April 30, 2013

    Report

    Report Number
    2028159-2013-00830
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 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

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. THREE LOT NUMBERS, MANUFACTURED IN DECEMBER 2012/JANUARY 2013, WERE IDENTIFIED WITH THE COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT IRRIGATION SOLUTION WENT INTO THE AIR LINE THROUGH THE AUTO STOPCOCK DURING A PROCEDURE. POOR CUTTING OF THE PROBE WAS ALSO REPORTED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188119 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PAK, 25+ 5.0 CPM VALVED STD J