BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT DELIVERY SYSTEM

    MDR report key: 4101625 · Received August 27, 2014

    Report

    Report Number
    1119279-2014-00206
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BAUSCH + LOMB SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 DURING INJECTING, THE DOCTOR DID NOT HAVE THE INJECTOR IN THE EYE FAR ENOUGH, CAUSING LENS TO COME OUT OF THE INCISION. CAPSULE DAMAGE AND A VITRECTOMY WERE REPORTED AS COMPLICATIONS OF THE PROCEDURE. ANOTHER LENS OF A DIFFERENT MODEL WAS PLACED IN THE SULCUS. THIS REPORT REFERS TO THE PATIENT'S LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO NEW INFORMATION HAS BEEN RECEIVED. THE LENS THAT WAS USED DURING THIS EVENT IS REPORTED UNDER 1119279-2014-00205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522670 SOFPORT DELIVERY SYSTEM FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB SURGICAL EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SOFPORT INTRAOCULAR LENS