BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT INTRAOCULAR LENS

    MDR report key: 4081118 · Received August 29, 2014

    Report

    Report Number
    1119279-2014-00209
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 31, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. 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 LENS INSERTION THE LENS HAPTIC BENT. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS OF A DIFFERENT MODEL WAS IMPLANTED IN THE SULCUS. VITREOUS LOSS WAS OBSERVED AND A VITRECTOMY WAS PERFORMED. SUTURES WERE PLACED. PLEASE REF MDR#: 1119279-2014-00210 FOR THE INSERTER THAT WAS USED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527645 SOFPORT INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB, INC. LI61AOR 4365904

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SOFPORT DELIVERY DEVICE