BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3102345 · Received April 30, 2013

    Report

    Report Number
    2028159-2013-00824
    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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED PROBLEM. THE COMPANY REPRESENTATIVE FOUND ALL VACUUM AND PRESSURE LEVELS WITHIN PRODUCT SPECIFICATIONS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE AIR/FLUID EXCHANGE WAS NOT WORKING DURING A VITRECTOMY PROCEDURE; THE AIR WAS GOING OUT BUT NOT IN. FOLLOWING A DELAY OF EIGHT MINUTES, THE UNIT WAS EXCHANGED AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187031 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1