BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23512846 · Received November 10, 2025

    Report

    Report Number
    3012236936-2025-000289
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    August 28, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811355
    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

    SECTION A6: RACE: UNKNOWN/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. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT SECTION G4: PMA/510(K) NUMBER IN THE INITIAL MDR WAS INADVERTENTLY SUBMITTED MISSING THE ¿P¿ BEFORE THE NUMERICAL VALUE. THE COMPLETE NUMBER IS P980040. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G4: PMA/510(K) NUMBER: P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT EXPRESSED DISSATISFACTION WITH THE LENS. IT IS UNKNOWN IF THERE WERE ANY DAILY ACTIVITIES THAT THE PATIENT WAS UNABLE TO PERFORM. THERE IS NO PLANNED SURGICAL INTERVENTION. THE PATIENT¿S RACE WAS ALSO PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT WAS RECEIVED FOR EVALUATION. 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 AND INSPECTED, AND NO FURTHER ISSUES WERE IDENTIFIED. 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, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION A6: RACE: WHITE SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: NOV 13, 2025 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINED OF THE INABILITY TO SEE MID-RANGE AND HALOS WHICH WERE MAKING IT CHALLENGING TO DRIVE AT NIGHT. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT ANY UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THERE WAS NO SURGICAL DELAY. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 PRE AND POST-OPERATIVELY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927376 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811355

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention