BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGN TORIC POSTERIOR CHAMBER IOL

    MDR report key: 16599248 · Received March 23, 2023

    Report

    Report Number
    0001313525-2023-70038
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    May 24, 2022
    Report Date
    February 24, 2023
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MJP
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS REMAINS IMPLANTED AND IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED. AS A SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED, THE ASSOCIATED DEVICE HISTORY RECORD WAS NOT REVIEWED. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, B5, G3, H2, H10/11.

    Description of Event or Problem · 0

    MEDWATCH REPORT 5115006 WAS RECEIVED. REPORTEDLY A CONSUMER EXPERIENCED IOL ROTATION THREE WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE RIGHT EYE. THE LENS WAS REPOSITIONED AND ALLEGEDLY MOVED OUT OF POSITION A SECOND TIME. REPORTEDLY, THE SURGEON WOULD NOT REPOSITION THE LENS A SECOND TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED, INDICATING THE EVENT WAS CAUSED BY Z-SYNDROME, AND A TORIC IOL ROTATION EVENT DID NOT TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361990 TRULIGN TORIC POSTERIOR CHAMBER IOL LENS, INTRAOCULAR, TORIC OPTICS MJP BAUSCH + LOMB BL1UT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention