BEUDAMED
    FDA Adverse Event Summary report: N

    CONSTELLATION LXT VISION SYSTEM

    MDR report key: 3162972 · Received May 8, 2013

    Report

    Report Number
    3162972
    Date Received
    May 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ALCON
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR LEFT EYE PPV/CRYO/SILICONE OIL PLACEMENT. SURGEON NOTED LARGE RETINAL TEAR AND DECIDED TO PLACE SILICONE OIL. WHILE INJECTING OIL, PRESSURE CAUSED SYRINGE TO POP OFF TUBING SCLEROTOMY INCREASED SIZE FROM 1MM TO 2MM. FORMER PARACENTESIS SITE REOPENED AND SURGEON HAD TO PLACE EXTRA STITCHES. ALSO, IRIS PROLAPSED DUE TO PRESSURE BUILD-UP AND A CUT OCCURRED TO PT'S CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202480 CONSTELLATION LXT VISION SYSTEM HQC ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention