BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23158687 · Received September 26, 2025

    Report

    Report Number
    3012236936-2025-000242
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    September 3, 2025
    Report Date
    January 6, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF THE INITIAL MDR REPORT, A TYPOGRAPHICAL ERROR WAS IDENTIFIED IN SECTION G4 (PMA/510(K) NUMBER) WHICH AN INCOMPLETE VALUE "980040" WAS ENTERED IN PLACE OF "P980040." THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY. SECTION G4: PMA/510(K) NUMBER: P980040 ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION?: YES DATE RETURNED TO MANUFACTURER: NOV. 5, 2025 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THERE WERE NO ISSUES OBSERVED ON THE LENS. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRT MODEL LENS. THE COMPLAINT ISSUES WERE NOT BE CONFIRMED DURING PRODUCT EVALUATION, AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 0

    SECTION A4: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, THE INFORMATION WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO PATIENT'S COMPLAINTS OF DYSPHOTOPSIA AND MYOPIC OUTCOMES. POST CATARACT SURGERY, THE PATIENT REPORTED AN INABILITY TO PERFORM ONE OR MORE DAILY ACTIVITIES. THE PRE-OPERATIVE TARGET REFRACTION WAS PLANO; HOWEVER, THE INITIAL POST-OPERATIVE REFRACTION WAS MEASURED AT -1.50+0.75X080. FOLLOWING EXPLANTATION, A NON-JOHNSON & JOHNSON LENS OF 18.5 DIOPTERS WAS IMPLANTED WITHOUT COMPLICATION. THERE WERE NO INTRAOPERATIVE ISSUES SUCH AS CAPSULE TEAR, INCISION ENLARGEMENT, SUTURES, OR UNPLANNED VITRECTOMY. NO ADDITIONAL MEDICATIONS BEYOND STANDARD CARE WERE REQUIRED. THE PATIENT'S OUTCOME WAS FAVORABLE, WITH REPORTED RESOLUTION OF HALOS. AT THE ONE-WEEK POST-OPERATIVE VISIT (POW1), THE REFRACTION WITH THE REPLACEMENT LENS WAS MEASURED AS PLANO +1.00X100. NO FURTHER INFORMATION PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936581 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention