BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST/DEWEY MNI PHACO TIP 30DEG

    MDR report key: 4080919 · Received August 28, 2014

    Report

    Report Number
    3019924-2014-00037
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    SIX WEEKS POST-OP CATARACT SURGERY, A PARTICLE WAS FOUND TO HAVE SETTLED ON THE PATIENT'S IRIS. A FOLLOW UP PROCEDURE WAS NEEDED TO REMOVE THE FRAGMENT. THE PIECE WAS REMOVED ADN THERE WAS NO SUBSEQUENT IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523564 MST/DEWEY MNI PHACO TIP 30DEG PHACO TIP HQC MICROSURGICAL TECHNOLOGY, INC. PT-29830-1

    Patients

    Seq Age Sex Outcome Treatment
    1