BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2901154 · Received January 4, 2013

    Report

    Report Number
    2028159-2012-02084
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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). THIS REPORT WAS MAILED TO FDA ON (B)(4) 2013. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED DURING A CATARACT EXTRACTION PROCEDURE. THE CUSTOMER TRIED DISCONNECTING AND RECONNECTING THE FOOTSWITCH SEVERAL TIMES, EXCHANGED THE HANDPIECE THREE TIMES, EXCHANGED THE CASSETTE, REBOOTED THE SYSTEM, AND FINALLY EXCHANGED THE SYSTEM BUT THE SECOND SYSTEM DISPLAYED THE SYSTEM MESSAGE AS WELL. THERE WERE MULTIPLE INCISIONS MADE RESULTING IN VITREOUS IN THE ANTERIOR CHAMBER. AFTER A 30 MINUTE DELAY, IT WAS NOTED THAT AN ANTERIOR VITRECTOMY WAS DONE AND THE INTRAOCULAR LENS WAS UNABLE TO BE INSERTED; THE INCISION WAS SUTURED AND THE CASE WAS ABORTED. PATIENT NOW HAS INCREASED INTRAOCULAR PRESSURE AND CORNEAL INFLAMMATION. THE PATIENT IS SCHEDULED FOR A SECOND PROCEDURE TO IMPLANT THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4785 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention