BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1913367 · Received November 11, 2010

    Report

    Report Number
    2028159-2010-02171
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOOTSWITCH WAS NOT GOING IN SEVERE WHEN YOU KICK THE SIDE PEDAL. ADDITIONAL INFO RECEIVED FROM THE TECHNICIAN STATED, THE REMOTE WAS USED TO NAVIGATE. THE FOOTSWITCH CORD WAS ALSO WIGGLED TO GET THE FOOTSWITCH TO WORK. THERE WAS A MOMENTARY DELAY, UNDER 30 SECONDS. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK