BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1662352 · Received April 16, 2010

    Report

    Report Number
    2028159-2010-00354
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    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 INFORMATION BECOMES AVAILABLE. (B) (4). ALTERNATE PROCEDURE PERFORMED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SURGEON CONVERTED TO AN ECCE IN ORDER TO COMPLETE THE SURGERY" (ALTERNATE PROCEDURE PERFORMED). PRODUCT PROBLEM(S): "TOUCH SCREEN IS ACTING IN AN ERRATIC MANNER" (ERRATIC DISPLAY). THE FACILITY REPORTED THE TOUCH SCREEN WAS FROZEN AND ACTING IN AN ERRATIC MANNER DURING A PROCEDURE. THE SURGEON CONVERTED TO AN EXTRA-CAPSULAR CATARACT EXTRACTION IN ORDER TO COMPLETE THE PROCEDURE. A MEDICAL DEVICE QUESTIONNAIRE WAS SENT TO THE SURGEON REQUESTING ADDITIONAL INFORMATION.

    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 Required Intervention