BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1872168 · Received October 14, 2010

    Report

    Report Number
    2028159-2010-01949
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE SYSTEM MESSAGE REPORTED. THERE WERE SOME SYSTEM MESSAGES NOTED IN THE EVENT LOG. THE COMPANY SERVICE REP WAS ABLE TO SAVE THE SURGEON SETTINGS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE COMPANY SERVICE REP REVIEWED WITH THE STAFF THE APPROPRIATE SET UP OF THE SYSTEM. THE COMPANY SERVICE REP EMPHASIZED ENSURING THE FITTINGS ARE TIGHT. THE CUSTOMER STATED SIX CASES WERE COMPLETED ON SEPTEMBER 16TH WITH NO PROBLEMS NOTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED AND THE HANDPIECE WON'T TUNE. THE SURGEON SETTINGS WON'T HOLD. THE SYSTEM MESSAGE WAS CLEARED AND THE SURGERY PROCEEDED. THERE WAS A DELAY EXPERIENCED WHILE THEY WERE TROUBLESHOOTING. NO PATIENT 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 CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK