BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3180197 · Received June 13, 2013

    Report

    Report Number
    2028159-2013-01135
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE COMPANY REP FOUND SYSTEM MESSAGE (SM) - (FAILURE TO TURN LAMP ON: LAMP NEEDS TO BE REPLACED) WAS GENERATED BY THE SYSTEM. THE XENON LAMP WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE 1 SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE WAS DETERMINED TO BE A NONCONFORMING XENON LAMP. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM'S XENON LAMP WAS "BURNED." THE CASE WAS COMPLETED USING AN ALTERNATE SYSTEM. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268034 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER L NA

    Patients

    Seq Age Sex Outcome Treatment
    1