BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 4810572 · Received May 29, 2015

    Report

    Report Number
    1313525-2015-01548
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 30, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 LENS WAS NOT RETURNED. THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. ONE RETAIN SAMPLE FROM THE SAME LOT 7373204 WAS DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. 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 ASYMMETRICALLY APPROXIMATELY THREE WEEKS POST IMPLANT. THE LENS WAS REPOSITIONED, BUT VAULTING OCCURRED ONCE AGAIN. THE PATIENT IS TO SEE ANOTHER DOCTOR FOR A SECOND OPINION. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ON FOLLOW UP EXAMINATION THE PHYSICIAN NOTED VERY LITTLE TILT AND VERY LITTLE INDUCED ASTIGMATISM AND EYE CORRECTS TO 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349695 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH & LOMB INCORPORATED BL1UT 7373204

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other