BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 21048804 · Received December 31, 2024

    Report

    Report Number
    3012236936-2024-000349
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    November 6, 2024
    Report Date
    March 24, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474813243
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: RETURNED TO MANUFACTURER ON: 2/3/2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: THE LENS WAS RECEIVED WRAPPED IN SURGICAL SPONGE WHICH WAS IN A BAG. THE LENS WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED CUT IN HALF. THE LENS WAS CLEANED AND PRESENTED WITH NO FURTHER ISSUES. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED DURING PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO VERY BLURRY VISION FOR DISTANCE, BOTHERSOME HALOS, NEGATIVE DYSPHOTOPSIA, AND MYOPIC MISS ON MEASUREMENTS. ANOTHER JOHNSSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DRT225 23.0 DIOPTER). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING A LOT BETTER POST-EXPLANT SURGERY; THE NEGATIVE DYSPHOTOPSIA IS GONE AND THE OVERALL FOUNDATION LOOKS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206984 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT375 05050474813243

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention