BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 6062671 · Received October 27, 2016

    Report

    Report Number
    0001313525-2016-00495
    Event Type
    Injury
    Date Received
    October 27, 2016
    Report Date
    September 30, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE LENS WAS NOT PROVIDED, AND THE LENS WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND PRODUCT EVALUATION COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LENS VAULTED (Z SYNDROME) APPROXIMATELY 6 MONTHS POST LENS IMPLANT. THERE IS ALSO VERY TIGHT FIBROSIS. THE SURGEON IS EVALUATING TREATMENT OPTIONS. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE LENS IS SCHEDULED FOR EXPLANT POST-OP PATIENT APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711266 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other