BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC IOL

    MDR report key: 3834512 · Received May 2, 2014

    Report

    Report Number
    2031924-2014-00082
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 LENS VAULTED ASYMMETRICALLY (Z SYNDROME) POST IMPLANT. ACCORDING TO THE SURGEON, THE PATIENT HAS ZONULAR WEAKNESS. THE SURGEON EXPLANTED THE LENS AND REPLACED IT WITH A DIFFERENT MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265280 TRULIGN TORIC IOL MJP; LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT 7368309

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other