BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3112095 · Received May 7, 2013

    Report

    Report Number
    2028159-2013-00793
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. DURING THE PHONE CALL, IT WAS FOUND THAT THE HANDPIECE ICON ON THE CUSTOMER'S SYSTEM WAS PINK, INDICATING THAT IT WAS NOT TUNED. THE TSS THEN ADVISED THE CUSTOMER TO TUNE THEIR PHACO HANDPIECE AND, THE REPORTED EVENT WAS RESOLVED. THE NEXT DAY, THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 1 RELATED REPORT FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO A NON-TUNED HANDPIECE, WHICH WAS ATTEMPTED TO BE USED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LOW ASPIRATION AND NO PHACO POWER DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THERE WAS A 1 HOUR DELAY TO TROUBLESHOOT. THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM AND CONSUMABLES WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199925 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1