BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2081366 · Received April 22, 2011

    Report

    Report Number
    2028159-2011-00431
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE ULTRASONIC (U/S) CONTROLLER PCB, COMMUNICATION DISTRIBUTION PCB, AND THE W19 CAN-CAN CABLE. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECS. ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING CATARACT PROCEDURE WITH IOL IMPLANT, THE SYSTEM DISPLAYED A SYSTEM MESSAGE INDICATING A VACUUM ERROR WAS DISPLAYED AND THE SOFTWARE LOCKED. THE SYSTEM WAS REBOOTED AND THE CASSETTE WAS EXCHANGED, BUT THE PROBLEM PERSISTED. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED AFTER A 10-15 MINUTES DELAY. THE NURSE REPORTED THAT THERE WAS NO HARM TO THE PT.

    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