BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3043010 · Received March 7, 2013

    Report

    Report Number
    2028159-2013-00398
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 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
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOOTSWITCH. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOOTSWITCH. THE COMPANY REPRESENTATIVE FOUND THAT FOREIGN DEBRIS WAS STUCK UNDER THE PEDAL, PREVENTING THE FOOTSWITCH FROM GOING TO POSITION 3. ONCE THE DEBRIS WAS REMOVED, THE FOOTSWITCH WAS ABLE TO GO INTO POSITION 3 AND THUS EXHIBIT PHACO POWER. 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 THE SYSTEM'S EVENT LOG DID NOT SHOW ANY RELATED SYSTEM MESSAGES TO NO PHACO POWER. THIS IS CONSISTENT WITH FINDING OF DEBRIS IN THE FOOTSWITCH. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO SOME DEBRIS GETTING STUCK IN THE PEDAL OF THE FOOTSWITCH, PREVENTING IF FROM GOING TO POSITION 3 FOR PHACO POWER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS NO PHACOEMULSIFICATION POWER WHEN THE FOOT PEDAL WAS DEPRESSED. HANDPIECE WAS SWITCHED OUT AND THE SETTINGS WERE CHANGED TO 100% BUT THERE WAS STILL NO PHACO POWER. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98370 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1