BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3960049 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00965
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SURGEON PRESSED ON THE FOOT PEDAL THE TEST THE CUTTER BEFORE ENTERING THE EYE, THE WHITE HAND PIECE OF THE PROBE "BLEW APART". THERE WAS NO PT CONTACT OR INVOLVEMENT IN THE FAILURE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT. NO ADDITIONAL INFO IS EXPECTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316160 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI ANTERIOR VITRECTOMY PAK