BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTPORT DELIVERY DEVICE

    MDR report key: 4360469 · Received December 18, 2014

    Report

    Report Number
    1119279-2014-00330
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 20, 2014
    Report Date
    December 1, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS REMOVED INTRAOPERATIVELY AS THE PT'S ANATOMY COULD NOT SUPPORT THE LENS. A VITRECTOMY WAS PERFORMED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE PLACED. THE PT WAS LEFT APHAKIC. IN THE SURGEON'S OPINION THE CAUSE OF THE EVENT WAS PT'S ANATOMY. PT IS DOING WELL. THERE IS NO PLANNED INTERVENTION THIS TIME. PT OPTED TO USE CONTACT LENS FOR VA CORRECTION. REF MDR# 1119279-2014-000329 FOR THE LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832843 SOFTPORT DELIVERY DEVICE FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SOFTPORT INTRAOCULAR LENS