BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2801107 · Received October 17, 2012

    Report

    Report Number
    2028159-2012-01622
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVAL IS IN PROGRESS. INVESTIGATION INCLUDING 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 SURGEON REPORTED THAT DURING A VITRECTOMY PROCEDURE, THE INFUSION PRESSURE WAS NOTED TO BE VERY HIGH EVEN THOUGH THE PRESSURE WAS SET TO 15MMHG. THE SURGEON INDICATED THE PAPILLA WAS HARDLY SUPPLIED WITH BLOOD, AND DESPITE THE 15 MMHG, THE BULBUS WAS "PALPATORY HARD." THE SURGEON PERFORMED PHACOEMULSIFICATION, PARS PLANA VITRECTOMY, AND MICRO PARACENTESIS USING THE SYSTEM. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 25G COMBINED PAK