BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3040425 · Received April 3, 2013

    Report

    Report Number
    2028159-2013-00601
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INABILITY TO USE REFLUX DURING A VITRECTOMY PROCEDURE. IT WAS NOTED THAT THERE WAS ONLY 5MM OF SOLUTION IN THE ASPIRATION CHAMBER. IT WAS ALSO NOTED THAT CUTTER ACTUATION WAS GOOD, HOWEVER THERE WAS ALWAYS AIR FLOW IN THE ASPIRATION TUBE. THE SURGEON FELT THAT THE AIR IN THE ASPIRATION TUBE WAS RELATED TO CUTTER ACTUATION AND DID NOT COME FROM THE PATIENT'S EYE. THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136421 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON-IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PAK| 25+ 5.0 CPM VALVED STD J