BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC ACCOMMODATING IOL

    MDR report key: 3412322 · Received October 4, 2013

    Report

    Report Number
    2031924-2013-00148
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 11, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED FIBRIN FORMATION AND CAPSULOPHIMOSIS APPROXIMATELY SEVEN WEEKS POST LENS IMPLANTATION WHICH CREATED CONTRACTION AND "Z" LIKE SYNDROME. THE SURGEON ATTEMPTED TO REPOSITION THE LENS WITH CAPSULAR TENSION RING (CTR) AND IT "Z" VAULTED THE OPSITE WAY. THE SURGEON REMOVED THE LENS APPROXIMATELY TWO MONTHS POST LENS IMPLANTATION AND IMPLANTED ANOTHER MODEL AND DIOPTER LENS. THIS REPORT PERTAINS TO THE PT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504168 TRULIGN TORIC ACCOMMODATING IOL MJP/LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other