BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS PHACO HANDPIECE

    MDR report key: 4924383 · Received July 16, 2015

    Report

    Report Number
    1920664-2015-00103
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 18, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE HANDPIECE WAS NOT PROVIDED THEREFORE, THE MANUFACTURING AND LOT RECORDS COULD NOT BE REVIEWED. THE FACILITY ALSO INDICATED THAT THE HANDPIECE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) INDICATING THAT A PARTICLE WAS FOUND IN THE PATIENT'S EYE DURING A PHACO PROCEDURE. THE DR. WAS ABLE TO RETRIEVE THE PARTICLE RIGHT AWAY. THERE WAS NO REPORT OF IMPACT OR CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463787 STELLARIS PHACO HANDPIECE HQC BAUSCH & LOMB, INC. BL3170

    Patients

    Seq Age Sex Outcome Treatment
    1