BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2043338 · Received February 25, 2011

    Report

    Report Number
    2028159-2011-00184
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE ULTRASOUND CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED FOR DIAGNOSTIC PURPOSES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGERY CENTER ADMINISTRATOR REPORTED THAT IN PREPARATION FOR CATARACT SURGERY THE SYSTEM PRIMED AND TESTED NORMALLY, AND THE INDICATOR LIGHT ON THE CONSOLE GAVE THE PROPER CONFIRMATION LIGHT, BUT THE HANDPIECE DID NOT SOUND RIGHT. DURING THE SURGERY, THE SURGEON NOTED THAT THERE WAS NOT MUCH TORSIONAL POWER. THE TIPS, HANDPIECES, AND CASSETTES WERE EXCHANGED, BUT THE TORSIONAL POWER REMAINED LOW. THE CATARACT WAS SOFT, SO THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO HARM OR INJURY TO THE PATIENT 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