BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23128073 · Received September 23, 2025

    Report

    Report Number
    3012236936-2025-000249
    Event Type
    Injury
    Date Received
    September 23, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: DEVICE DATE RETURNED TO MANUFACTURER: 13-OCT-2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE A SPECIMEN CUP. DURING A VISUAL INSPECTION, THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED PARTIALLY CUT AND COATED IN AN UNKNOWN LIQUID. THE LENS WAS CLEANED AND INSPECTED, REVEALING SCRATCHES ON THE LENS AND A MARK ON ONE OF THE HAPTICS. NO FURTHER EVALUATION WAS PERFORMED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER ISSUES OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED; THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER (PO) NUMBER. 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

    ADDITIONAL INFORMATION: SECTION B-3 DATE OF EVENT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. THE BEST DATE ESTIMATION IS BETWEEN 09-APR-2025 AND 03-SEP-2025 (IOL IMPLANT AND EXPLANT DATES). SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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 REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE DRT225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF BLURRY VISION, HALOS AND GLARE ISSUES AT WORK, AND ULTIMATELY DISSATISFACTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL). DURING THE LENS EXCHANGE PROCEDURE THE INCISION WAS ENLARGED HOWEVER, THERE WAS NO COMPLICATIONS, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS GREAT. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402426 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention