BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3063326 · Received March 1, 2013

    Report

    Report Number
    2028159-2013-00339
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS NOT ABLE TO CONFIRM THE SYSTEM MESSAGE (TUNE FAILED-LOOSE TIP) REPORTED. THE U/S PRINTED CIRCUIT BOARD (PCB) CONTROLLER WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO 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 4 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS PHACO HANDPIECE OR SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSING UNIT MANAGER REPORTED A SYSTEM MESSAGE DISPLAYED AT TIME OF INCREASING ULTRASOUND DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE HANDPIECE AND TIP WERE EXCHANGED, CASSETTE WAS CHANGED, AND THE SYSTEM REBOOTED. FOLLOWING A DELAY OF 20 MINUTES, THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THE FOLLOWING SURGERIES PLANNED ON THAT DAY WITH THIS SYSTEM WERE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90220 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON MANUFACTURING, LTD. INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OZIL TORSIONAL PHACO HANDPIECE