BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS PHACO HANDPIECE

    MDR report key: 6439856 · Received March 28, 2017

    Report

    Report Number
    0001920664-2017-00132
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    February 27, 2017
    Report Date
    February 27, 2017
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770480852
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE BL3170 HANDPIECE, SERIAL NUMBER (B)(4) WAS RETURNED. NO VISUAL DEFECTS WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS SYSTEM. THE HANDPIECE DATA DISPLAYED TUNE COUNT 251, ON-TIME 5171051 AND AVERAGE POWER 0. THE HANDPIECE TUNED, PRIMED AND FUNCTIONED AS INTENDED. IN ADDITION A FILTER TEST WAS PERFORMED BY RUNNING WATER THROUGH THE IRRIGATION TUBE OUT ONTO A 0.45 MICRON FILTER. THE WATER WAS THEN VACUUMED OFF THROUGH THE FILTER IN AN ATTEMPT TO TRAP ANY POSSIBLE PARTICLES. MICROSCOPIC EXAMINATION OF THE FILTER FOUND TWO VERY SMALL DARK COLORED PARTICLES, THREE FIBER-LIKE PARTICLE AND ONE LARGER DARK PARTICLE THAT HAS THE APPEARANCE OF ORGANIC MATERIAL. NONE OF THE PARTICLES HAD THE APPEARANCE OF METAL. THIS FILTER WILL BE SENT TO THE LAB FOR ANALYSIS OF THE PARTICLES. THE LAB RESULTS STATE "CONCLUSION:THESE ANALYSES INDICATE THAT THE DARK COLORED PARTICLES ON FILTER CONSIST OF CALCIUM CARBONATE AND MINERAL DEPOSITS."

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY WAS REVIEWED AND FOUND TO MEET MANUFACTURING SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER SAYS THEY ARE GETTING PARTICULATE IN THE PATIENTS WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223144 STELLARIS PHACO HANDPIECE PHACOEMULSIFICATION HANDPIECE HQC BAUSCH + LOMB BL3170 00757770480852

    Patients

    Seq Age Sex Outcome Treatment
    1