BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 5054361 · Received September 3, 2015

    Report

    Report Number
    2028159-2015-08129
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR SYSTEM LIGHTS 1 AND 2 WERE OUT. A SERVICE REPRESENTATIVE VISITED THE CUSTOMER SITE AND EVALUATED THE SYSTEM. PER THE SERVICE REQUEST, THE SERVICE REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT AND REPLACED AN ASSY, SHIP, XENON LAMP. THE SERVICE REPRESENTATIVE PERFORMED PREVENTATIVE MAINTENANCE (PM) AND FOUND THE SYSTEM TO MEET SPECIFICATIONS PER SERVICE TEST PROCEDURE (STP). THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE ASSY, SHIP, XENON LAMP (P/N 212-3338-501). HOWEVER, DETERMINING IF THE XENON LAMP IS NONCONFORMING OR PAST ITS RATED LIFE EXPECTANCY CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LIGHTS ON PORT 1 AND 2 WENT OUT DURING A RETINAL PROCEDURE. ADDITIONAL EVENT DETAILS WERE REQUESTED. NEW INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING SOMEONE HAD PASSED BY THE BACK OF THE MACHINE AND BUMPED INTO IT DURING THE PROCEDURE. THE CASE WAS COMPLETED BY USING BACK-UP LIGHTING. THE BUTTON ON THE BACK OF THE SYSTEM WAS RESET AND THE LIGHTS 1 AND 2 STARTING WORKING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586312 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other