BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALCON CONSTELLATION VISION SYSTEM

    MDR report key: 5096380 · Received September 17, 2015

    Report

    Report Number
    MW5056352
    Event Type
    Death
    Date Received
    September 17, 2015
    Date of Event
    June 22, 2015
    Report Date
    September 17, 2015
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR AN ELECTIVE RIGHT EYE 23 GAUGE VITRECTOMY AND SCLERAL BUCKLE. DURING THE END OF THE VITRECTOMY, PATIENT SUDDENLY DEVELOPED CHOROIDAL ELEVATION BOTH NASALLY AND TEMPORALLY. THE INTRAOCULAR PRESSURE WAS ELEVATED TO ABOUT 60 WHILE THE AIR FLUID EXCHANGE HAD BEEN PERFORMED. AT THE SAME TIME THIS OCCURRED, AN ATTEMPT WAS ABOUT TO BE MADE TO CUT DOWN ON THE CHOROID TO RELIEVE THE PRESUMED CHOROIDAL HEMORRHAGE, PATIENT SUDDENLY DESATURATE WITH THE OXYGEN LEVEL DROPPING. CODE BLUE WAS INITIATED AND PATIENT WAS INTUBATED. PATIENT SUBSEQUENTLY EXPIRED DESPITE ALL RESUSCITATIVE EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616277 ALCON CONSTELLATION VISION SYSTEM ALCON CONSTELLATION VISION SYSTEM HQC ALCON LABORATORIES, INC. XT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death