BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3231978 · Received July 15, 2013

    Report

    Report Number
    2028159-2013-01451
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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 INFO BECOMES AVAILABLE. A SAMPLE HAS BEEN RECEIVED AND IS AWAITING INSPECTION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE INFUSION PRESSURE WAS NOT WORKING PROPERLY AND THE EYE WENT SOFT DURING A PARS PLANA VITRECTOMY WITH MEMBRANE PEEL PROCEDURE. THE FLUID AIR EXCHANGE TUBING WAS EXCHANGED IN LESS THAN FIVE MINUTES AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325822 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR PRM 23 5.0 CPM| PAK