BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 6207636 · Received December 27, 2016

    Report

    Report Number
    0001313525-2016-00881
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L FOR EVALUATION. VISUAL INSPECTION FOUND THE LENS IS TORN IN TWO PIECES. THE OPTIC IS CUT OR TORN IN HALF AND THE HAPTICS ARE BENT. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RETURNED TO B+L FOR EVALUATION; THEREFORE, PRODUCT EVALUATION COULD NOT BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE DUE TO A SMALL ANTERIOR CAPSULE TEAR NOTED DURING LENS INSERTION. ANOTHER LENS OF DIFFERENT MODEL WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857268 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT 7573404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other