BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2891621 · Received December 7, 2012

    Report

    Report Number
    2028159-2012-01908
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY BIOMEDICAL TECHNICIAN EXAMINED THE SYSTEM AND DID NOT FIND ANY ISSUE WITH THE SYSTEM. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN BY ITSELF DURING A VITREO-RETINAL PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED WITH A BACKUP MACHINE FOLLOWING A DELAY OF LESS THAN 15 MINUTES. THERE WAS NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1