BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 5023984 · Received August 23, 2015

    Report

    Report Number
    0001313525-2015-02567
    Event Type
    Injury
    Date Received
    August 23, 2015
    Report Date
    July 27, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 TO THE MANUFACTURER FOR EVALUATION. ONE RETAIN SAMPLE FROM THE SAME LOT (023916) 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 INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS UNHAPPY WITH VISUAL RESULTS POST BILATERAL LENS IMPLANTS. THE PATIENT'S DOCTOR PERFORMED A YAG LASER SUGERY TO BOTH EYES FOR SCAR TISSUE. REPORTEDLY PATIENT'S VISION AT 1 1/2 TO 3 FEET IS ALRIGHT, BUT BEYOND 3 FEET EVERYTHING IS BLURRY. THE PATIENT INDICATED THAT A PRK PROCEDURE IS SCHEDULED. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557092 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH & LOMB INCORPORATED BL1UT 023916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other