BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23441041 · Received October 31, 2025

    Report

    Report Number
    3012236936-2025-000270
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 29, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811362
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT "NO INFORMATION" WAS MISTAKENLY SELECTED FOR SECTION D9 OF THE INITIAL MDR REPORT; THE CORRECT SELECTION IS "NO." WHICH SHOULD HAVE BEEN CHOSEN. IT WAS ALSO NOTED THAT INCOMPLETE PMA/510(K) NUMBER WAS INADVERTENTLY ENTERED IN THE SECTION "G4" OF THE INITIAL MDR REPORT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THAT INFORMATION. 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. 13, 2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES 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. THE COMPLAINT ISSUES REPORTED COULD 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, TORIC II INTRAOCULAR LENS (IOL) WAS IMPLANTED DURING CATARACT SURGERY IN THE LEFT EYE. POSTOPERATIVELY, THE PATIENT EXPERIENCED INTOLERABLE GLARE AND POOR-QUALITY VISION THAT COULD NOT BE CORRECTED BEYOND 20/40, EVEN WITH GLASSES. THESE SYMPTOMS AFFECTED THE PATIENT¿S ABILITY TO PERFORM DAILY ACTIVITIES, INCLUDING DRIVING AT NIGHT. ATTEMPTS TO ADAPT, SUCH AS WALKING AROUND THE CLINIC WITH TRIAL FRAMES, DID NOT RESOLVE THE ISSUE, AND THE PATIENT REPORTED A DECREASE IN VISUAL ACUITY. A SLIT-LAMP EXAMINATION IDENTIFIED VISUALLY SIGNIFICANT LENS OPACITY AS A PRIMARY FACTOR CONTRIBUTING TO THE REDUCED VISUAL ACUITY. IT WAS INDICATED THAT THE PATIENT HAS NATURALLY OCCURRING ASTIGMATISM AND WANTED TO HAVE REDUCED DEPENDENCE ON GLASSES. THEREFORE, ELECTED TO PROCEED WITH THE LENS EXPLANTATION. THE ORIGINAL LENS WAS EXPLANTED AND REPLACED WITH COMPETITOR'S TORIC LENS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT INJURY WAS REPORTED DURING THE EXPLANTATION, AND NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385640 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811362

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention