BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1851096 · Received September 30, 2010

    Report

    Report Number
    2028159-2010-01861
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF THE PHACO HANDPIECE DIRECTIONS FOR USE (DFU) WAS PROVIDED TO THE CUSTOMER. THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED SEVERAL INCIDENTS OF ENDOPHTHALMITIS. THIS EVENT LASTED 1 DAY. THE PT WAS TREATED WITH CRYOPEXY AND INJECTION OF GAS. THE SURGEON INJECTED INTRAVITREAL AMYKACIN AND VANCOMYCIN. THE VISCOELASTIC USED IN THIS PT WAS NOT RECORDED. THE AQUEOUS SCRAPINGS WERE CULTURED AND THE RESULTS SHOWED NO GROWTH. THE CUSTOMER HAS NOT SPECIFIED THAT ANY ALCON PRODUCTS ARE INVOLVED. HOWEVER, THEY DO USE ALCON PRODUCTS.

    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 70 YR Required Intervention CUSTOM PAK