BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC IOL

    MDR report key: 4081110 · Received August 28, 2014

    Report

    Report Number
    2031924-2014-00216
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    July 21, 2014
    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

    CAPSULAR CONTRACTION SYNDROME WAS REPORTED POST LENS IMPLANT. THE DOCTOR ATTEMPTED A PERIPHERAL YAG CAPSULOTOMY ON PATIENT'S RIGHT EYE, BUT INDICATED THAT THE YAG TREATMENT MAY NOT HAVE BEEN SUCCESSFUL. ACCORDING TO THE SURGEON, THE PATIENT MAY NEED ADD'L YAG LASER TREATMENT SESSIONS. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523569 TRULIGN TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH & LOMB BL1UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other