BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3102231 · Received April 30, 2013

    Report

    Report Number
    2028159-2013-00825
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 2, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE BOTTOM OF THE FLUIDICS MODULE WAS WET. THE FLUIDICS MODULE WAS REPLACED. NO OTHER PROBLEMS WERE FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A ROOT CAUSE HAS NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SYSTEM MESSAGE DISPLAYED DURING A VITRECTOMY PROCEDURE. THE SYSTEM WAS REBOOTED AND THE SAME CASSETTE THAT WAS IN THE SYSTEM WAS ABLE TO BE REPRIMED. FOLLOWING A SIGNIFICANT DELAY OF UNSPECIFIED DURATION, THE CASE WAS ABLE TO BE COMPLETED WITH THE SAME EQUIPMENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187830 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER XT NA

    Patients

    Seq Age Sex Outcome Treatment
    1