BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23241188 · Received October 7, 2025

    Report

    Report Number
    3012236936-2025-000248
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    July 29, 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
    OK, 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. SECTION D9: RETURNED TO MANUFACTURER ON: NOVEMBER 5, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED, INSPECTED, AND NO ISSUES THAT COULD CONTRIBUTE TO THE COMPLAINT ISSUE WERE OBSERVED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRT MODEL LENS. NO FURTHER EVALUATION WAS PERFORMED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, 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, A5 AND A6: 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 THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT SURGERY IN THE RIGHT EYE TO REMOVE A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (MODEL DRT375). THE PROCEDURE WAS PROMPTED BY THE PATIENT'S INABILITY TO ADAPT TO NEGATIVE DYSPHOTOPSIA AND REPORTED POOR VISION. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO COMPLICATIONS SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT IS CURRENTLY IN THE HEALING PHASE. NO ADDITIONAL INFORMATION WAS 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
    222271 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT375

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention