BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2102241 · Received May 19, 2011

    Report

    Report Number
    2028159-2011-00572
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    January 27, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE OCCURRED AT THE BEGINNING OF A SURGICAL PROCEDURE. THE FOOTSWITCH WAS BLOCKED RESULTING IN SYSTEM FAILURE. THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE POSTPONED. IN ADDITION, THE FOLLOWING SURGICAL PROCEDURES OF THE DAY HAD TO BE POSTPONED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1