BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2240963 · Received August 17, 2011

    Report

    Report Number
    2028159-2011-00984
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES WAS CONTACTED AND RECOMMENDED TO THE CUSTOMER THAT THEY TRY A DIFFERENT HANDPIECE AND TO CHANGE THE VACUUM PRESET TO 50 IN I/A, WHICH SEEMED TO HELP. IT WAS CONFIRMED BY THE CUSTOMER THAT THE HANDPIECE WAS NEVER EXCHANGED. A SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND COULD NOT REPLICATE THE REPORTED EVENT. HOWEVER, THE REPRESENTATIVE DID FIND THAT THE REMOTE WAS STUCK IN THE DOWN POSITION, WHICH HELD SETTINGS TO ZERO. THE REPRESENTATIVE THEN RESTORED DOCTOR SETTINGS AND ORDERED A NEW REMOTE. THE SERVICE REPRESENTATIVE COULD NOT REPLICATE THE REPORTED EVENT, AND FOUND THE SYSTEM TO MEET SPECIFICATIONS. NO SAMPLES WERE ALSO RETURNED TO THE (B)(4) FOR FURTHER ROOT CAUSE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED POOR PHACO AND VACUUM COULD NOT BE DETERMINED AND IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED POOR PHACO POWER AND VACUUM WHILE IN IRRIGATION/ASPIRATION (I/A) MODE. NO PT HARM WAS REPORTED. ADDITIONAL INFO WAS RECEIVED FROM THE CUSTOMER INDICATING THAT IN ADDITION TO THE POOR VACUUM AND PHACO POWER, THE SYSTEM WAS ALSO MAKING A NOISE DURING SURGERY AND THE REMOTE CONTROL INDICATED THE BATTERY WAS LOW. THE I/A POWER WAS MANUALLY RESET AND THE CASE WAS COMPLETED WITH A TORSIONAL AMPLIFIER. THE REPORTED EVENT RESULTED IN A 20-30 MINUTE DELAY AND RESULTED IN THE CANCELLATION OF SIX SUBSEQUENT CASES.

    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 KELMAN US TURBOSONIC MICROTIP FLARED| DUOVISC