BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY VISION SYSTEM

    MDR report key: 3021190 · Received March 24, 2013

    Report

    Report Number
    3021190
    Event Type
    Malfunction
    Date Received
    March 24, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ALCON
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INFINITY PRIMED AND TUNED, READY TO GO. MD USED THE PEDAL TO START. MACHINE FAILED, BLACKED OUT, SCREEN-SOFTWARE FAILURE. ABOUT A WEEK LATER, THE REPAIR WAS MADE AND THE FOLLOWING WAS REPLACED: SPACER, C-CLIP, SOLENOID.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?KELMAN PHACOEMULSIFICATION (KPE) AND INTRAOCULAR LENS (IOL) IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121188 INFINITY VISION SYSTEM FLUIDIC, PHACOEMULSIFICATION/PHACOFRAGMENTATION HQC ALCON INFINITY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR