BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2214103 · Received July 18, 2011

    Report

    Report Number
    2028159-2011-00838
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PIECE OF METAL CAME OUT OF THE PORT OF THE HANDPIECE WITH NO PT IMPACT. ADD'L INFO WAS RECEIVED FROM THE DOCTOR INDICATING THE PARTICLE WENT INTO THE ANTERIOR CHAMBER RIGHT AFTER THE HANDPIECE WAS INSERTED INTO THE EYE AND IRRIGATION BEGAN. THE PARTICLE WAS REMOVED USING FORCEPS. THE HANDPIECE WAS THEN SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO FURTHER INCIDENTS. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other