BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1791466 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01386
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOOTSWITCH 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

    ADVERSE EVENT(S): ¿NO PT HARM REPORTED¿ (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): ¿FOOTSWITCH WORKING INTERMITTENTLY¿ (DEVICE STOPS INTERMITTENTLY); ¿SYSTEM MESSAGE DISPLAYED¿ (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED THE FOOTSWITCH WAS WORKING INTERMITTENTLY. THE CUSTOMER STATED A SYSTEM MESSAGE WOULD DISPLAY STATING THE FOOTSWITCH WAS UNPLUGGED. THE FOOTSWITCH WAS CHECKED AND IT WAS PLUGGED. THE SYSTEM MESSAGE WOULD CLEAR AND SURGERY WOULD CONTINUE. THE FOOTSWITCH WAS USED ALL DAY WITH 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 UNK