BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3013112 · Received March 15, 2013

    Report

    Report Number
    2028159-2013-00402
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 18, 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
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PROBE DID NOT WORK DURING A VITRECTOMY PROCEDURE. THE PROBE PASSED THE PRIMING TEST. WHEN THE PROBE WAS INSERTED INTO THE EYE IT MADE A "FUNNY" SOUND AND DID NOT PERFORM. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110710 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE COMBINED PAK