BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2043077 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00287
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, PERFORMED PREVENTIVE MAINTENANCE AND REPLACED THE SOLENOID SPACER. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. FOOTSWITCH AND FOOTSWITCH CABLE EXCHANGED. 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 INFO BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/25/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED JUST BEFORE THE START OF A PROCEDURE. THE PROCEDURE OF THREE PTS', WHO WERE READY FOR SURGERY WERE CANCELED. ADDITIONAL INFO RECEIVED FROM THE SURGEON INDICATED THE ENTIRE SURGICAL DAY HAD TO BE CANCELED. THREE PTS WERE SCHEDULED AND HAD RECEIVED DILATING DROPS AND ONE PT HAD RECEIVED A RETROBULBAR INJECTION.

    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