BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1940107 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02466
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 3, 2010
    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
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE IV POLE WOULD NOT WORK AND A SYSTEM MESSAGE WAS RECEIVED DURING SURGERY. THE SURGERY WAS SWITCHED OUT AND COMPLETED WITH A SECOND SYSTEM. THERE WAS NO PT IMPACT REPORTED, BUT THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THE CUSTOMER REPORTED THAT DUE TO HER INTENSE DAILY ACTIVITIES, SHE WOULD NOT BE ABLE TO PROVIDE ANY ADD'L INFO.

    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