BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23197111 · Received October 1, 2025

    Report

    Report Number
    3012236936-2025-000246
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    July 8, 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
    TX, 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 REVEALED THAT THE LENS WAS CUT IN HALF AND ONE HAPTIC WAS DETACHED AND MISSING. NO ISSUES THAT COULD CONTRIBUTE TO THE COMPLAINT ISSUE WERE IDENTIFIED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRT MODEL LENS. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. 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 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD BILATERAL IMPLANTATION OF PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS). POST-OPERATIVELY, THE PATIENT NOTED DIFFICULTY WITH NIGHT DRIVING AND BLURRY DISTANCE VISION DURING NIGHT AND DAY. THESE SYMPTOMS WERE IDENTIFIED DURING A FOLLOW-UP EXAMINATION. THE INTRAOCULAR LENSES WERE EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE ON THE SAME DAY. THERE WERE NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, AND NO DELAY IN PROCEDURE REPORTED. THE PATIENT HAS FULLY RECOVERED. THE BEST CORRECTED VISUAL ACUITY FOR THE RIGHT EYE WAS 20/20 BOTH PRE-OPERATIVELY AND POST-OPERATIVELY. FOR THE LEFT EYE, IT WAS 20/20 PRE-OPERATIVELY AND POST-OPERATIVELY WAS 20/25. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTIONS FOR USE WERE FOLLOWED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623235 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention