BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 5408972 · Received February 3, 2016

    Report

    Report Number
    0001313525-2016-00037
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    November 10, 2015
    Report Date
    December 4, 2015
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ONE RETAIN SAMPLE FROM THE SAME LOT (023856) WAS 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 CURRENT INFORMATION, THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    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 A PATIENT PRESENTED WITH A "MYOPIC SHIFT DUE TO SMALL EYE AND ANTERIOR VAULT OF LENS" APPROXIMATELY 5 WEEKS POST LENS IMPLANT IN THE LEFT EYE. THE SURGEON INDICATED THE LIKELY CAUSE OF THE EVENT WAS "SMALL EYE, ANTERIOR VAULT OF THE LENS". THE PATIENT IS HAPPY WITH NEAR VISION, BUT MAY CONSIDER MILD MYOPIC LASIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64125 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT 023856

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other