BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913561 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02042
    Event Type
    Malfunction
    Date Received
    December 21, 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
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE 25+ PROBE FOR A COMPLAINT ON ¿VIT CUTTER CANNOT CUT IN HIGH SPEED.¿ THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING BECAUSE THE CUTTER WAS IN THE CLOSED POSITION AND SURGICAL DEBRIS ON THE PORTFACE. THE SAMPLE WAS FUNCTIONALLY TESTED AND FOUND TO BE NONCONFORMING FOR ACTUATION (CUTTER REMAINED IN THE CLOSED POSITION). THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. THERE WAS NO INNER CUTTER MOVEMENT PRIOR TO DISASSEMBLY. THE CUTTING EDGE OF THE INNER CUTTER EXHIBITED NICKS, GOUGES, AND SIGNIFICANT WEAR MARKS. THE ROOT CAUSE WAS ATTRIBUTED TO A DAMAGED INNER CUTTER. THERE IS EVIDENCE THAT THE PROBE HAD BEEN USED; NICKS, GOUGES, AND WEAR MARKS ON THE CUTTING EDGE INDICATES THAT THE PROBE MAY HAVE BEEN INITIALLY WORKING PROPERLY AND ONLY DAMAGED SOMETIME DURING SURGERY. PROBES ARE 100% VISUALLY AND FUNCTIONALLY TESTED DURING MANUFACTURING. A NONCONFORMANCE (EXAMPLE, POOR CUTTER MOVEMENT) WOULD HAVE BEEN DETECTED DURING ASSEMBLY AND TESTING AND SUBSEQUENTLY REMOVED FROM THE LOT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE CUTTER COULD NOT CUT AT HIGH SPEED DURING A PROCEDURE. THEY CHANGED TO A NEW PAK TO RESOLVE THE ISSUE. THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1