BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 496303 · Received November 12, 2003

    Report

    Report Number
    2028159-2003-00218
    Event Type
    Malfunction
    Date Received
    November 12, 2003
    Date of Event
    October 13, 2003
    Report Date
    October 13, 2003
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    METAL FLAKES COMING INTO EYE DURING LENS FRAGMENTATION USING PHACO HANDPIECE. MOST PARTICLES IRRIGATED OUT OF EYE. PROGNOSIS REPORTED AS GOOD. VISUAL ACUITY 20/70 ONE WEEK POST-OP. EYE IS QUIET. TINY SHINY FRAGMENTS ON IRIS SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OPHTHALMIC SURGERY SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR