BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1101751 · Received August 7, 2008

    Report

    Report Number
    2028159-2008-00283
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS QUARANTINED THE SYSTEM. THE SURGEON STATED HIS PARTNER NOTICED THAT THE SYSTEM BULB EXPIRED WHILE PERFORMING A CASE AN THE CASE WAS THEN COMPLETED USING THE ACCURUS HALOGEN SOURCE. SHORTLY THEREAFTER THE BULB WAS CHANGED BY THE IN HOUSE SERVICING BIOMEDICAL DEPARTMENT (GE), WITHOUT HIS AWARENESS. THE SURGEON IS REQUESTING THE ALCON PERFORM SERVICING AND INVESTIGATION OF THE UNIT PRIOR TO RISK MANAGEMENT EVAL SINCE THEY MAY POTENTIALLY CAUSE THE INVESTIGATION TO BE INACCURATE AS A RESULT. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 8/7/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON A POST OPERATIVE EXAMINATION THE PT EXHIBITED SIGNS OF POTENTIAL PHOTOTOXICITY. THE SURGEON DESCRIBED A WELL CIRCUMSCRIBED 4-5 DISC DIAMETER TEMPORAL PARAFOVEAL PIGMENTARY DISRUPTION TO THE RETINAL PIGMENT EPITHELIUM. THE PT ALSO EXHIBITED DECREASE IN BEST CORRECTED VISUAL ACUITY. THE SURGEON HAS BEEN OPERATING UNDER 80% LIGHT OUTPUT THROUGHOUT ALL OF HIS CASES. HE IS UNAWARE OF THE LUMEN OUTPUT THAT IS EMITTED FROM THE LIGHT SOURCE. HE RECENTLY WAS INFORMED THAT BULB CHANGE WAS PERFORMED BY THEIR IN HOUSE SERVICING BIOMEDICAL DEPARTMENT (GE) AROUND THE TIME WHICH HE REPORTS THE PHOTOTOXICITY EVENT. THE SURGEON STATED THE PT'S POTENTIAL OUTCOME IS GUARDED.

    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 NI Disability