BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1823441 · Received August 25, 2010

    Report

    Report Number
    2028159-2010-01581
    Event Type
    Injury
    Date Received
    August 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SALES REP EXAMINED THE SYSTEM AND FOUND NO PROBLEMS. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "PHOTO-TOXICITY" (PHOTOTOXICITY). PRODUCT PROBLEM(S): "NO DEVICE PROBLEM REPORTED" (NO KNOWN DEVICE PROBLEM). A SURGEON REPORTED A PT WITH POST-OPERATIVE SYMPTOMS HE BELIEVES IS CONSISTENT WITH PHOTOTOXICITY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM ENDOILLUMINATOR MPA ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention