BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3963348 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00940
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR.
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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 REGIONAL MANAGER REPORTED THE LASER WOULD NOT ''FIRE UP'' PRIOR TO A PROCEDURE. HE ADVISED HE WAS JUST TESTING THE SYSTEM - THIS WAS NOT RELATED TO ANY SCHEDULED PROCEDURE OR PATIENT. THE UNIT WAS TURNED ON AND DISPLAYED A SM ABOUT THE LASER. HE DID NOT RECALL THE NUMBER OR THE TEXT OF THE SYSTEM MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301370 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR. L NA

    Patients

    Seq Age Sex Outcome Treatment
    1