BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST DEWEY 0.9 MINI A1 BENT PHACO TIP 30 DEGREE

    MDR report key: 6993361 · Received November 1, 2017

    Report

    Report Number
    3019924-2017-00020
    Event Type
    Injury
    Date Received
    November 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HQC
    PMA / PMN Number
    K943672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORTING DR. THERE WAS NO PROBLEM WITH THE PRODUCT. DEVICE WAS NOT RETURNED AND THEREFORE MST COULD NOT EVALUATE THE DEVICE TO CONFIRM THE COMPLAINT.THE PATIENT HAD 20/20 VISION POST OP.

    Description of Event or Problem · 1

    ALLEGEDLY DURING REMOVAL OF THE CATARACT, AN EXPERIENCED RESIDENT DETECTED A CAPSULE BREAK WHILE REMOVING THE SECOND QUADRANT. THIS RESULTED IN AN ANTERIOR VITRECTOMY AND THE PLACEMENT OF A SULCUS LENS (3 PIECE ACRYLIC). TWO DEVICES WERE IMPLICATED IN THE EVENT. IT IS UNKNOWN IF THE DAMAGE OCCURRED WITH A "CHOPPER" OR THE PHACO TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773875 MST DEWEY 0.9 MINI A1 BENT PHACO TIP 30 DEGREE PHACOEMULSIFICATION TIP HQC MICROSURGICAL TECHNOLOGY INC PT-30930-R 090127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other