BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST

    MDR report key: 1692013 · Received May 13, 2010

    Report

    Report Number
    3019924-2010-00001
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    March 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED A CORNEAL BURN DURING PHACOEMULSIFICATION OF A CATARACT. THE SURGEON NOTICED THE BURN WHILE INSERTING THE INTRAOCULAR LENS, BUT BELIEVES IT HAPPENED EARLY IN THE PROCEDURE. A STITCH WAS REQUIRED TO SECURE THE INCISION SITE. EXPECTED OUTCOME FOR THE PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST HQC - PHACOEMULSIFICATION NEEDLE HQC MICROSURGICAL TECHNOLOGY, INC. PT-314XX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention