BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFEYE CAPSULAR TENISON RING (CTR)

    MDR report key: 17435502 · Received August 1, 2023

    Report

    Report Number
    0001313525-2023-70097
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    June 7, 2023
    Report Date
    June 8, 2023
    Manufacturer
    MORCHER GMBH
    Product Code
    MRJ
    UDI-DI
    10757770529992
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION OF AN IN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE LENS ROTATED OUT OF POSITION. THE LENS WAS REPOSITIONED, AND A CAPSULAR TENSION RING WAS PLACED. ALLEGEDLY THE LENS MOVED OUT POSITION A SECOND TIME. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. THE CAPSULAR TENSION RING REMAINS IMPLANTED. THERE WERE NO INJURIES REPORTED. IN THE SURGEON''S OPINION THE MOST LIKELY CAUSE FOR EVENT IS HAPTIC NOT CONTACTING CAPSULAR BAG ADEQUATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335285 FORTIFEYE CAPSULAR TENISON RING (CTR) RING, ENDOCAPSULAR MRJ MORCHER GMBH CTR10L CACBKB 10757770529992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ENVISTA TORIC INTRAOCULAR LENS