BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST ALLEGRO

    MDR report key: 5062698 · Received September 8, 2015

    Report

    Report Number
    3019924-2015-00029
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR AN EVALUATION. THE SURGEON REPORTED THAT SHE WAS PERFORMING VISCO REMOVAL UNDER THE IOL WHEN CONTACT WAS MADE AND A SMALL TEAR WAS CREATED IN THE POSTERIOR CAPSULE. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING VISCO REMOVAL THE SURGEON EXPERIENCED A CAPSULE TEAR UNDER THE IOL. A POSTERIOR CAPSULORHEXIS WAS PERFORMED UNDER THE LENS AND A VITRECTOMY WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594137 MST ALLEGRO OPHTHALMIC CANNULA HMX MICROSURGICAL TECHNOLOGY INC AT-0001-R 069454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other