BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 21756279 · Received April 2, 2025

    Report

    Report Number
    3012236936-2025-000090
    Event Type
    Injury
    Date Received
    April 2, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811263
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS AFTER THE LENS IMPLANTATION ON (B)(6) 2024. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAIN IMPLANTED IN THE EYE. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137- BLURRED VISION- USED TO INDICATE BLURRED VISION AND POOR NEAR VISION SECTION H6: HEALTH EFFECT - IMPACT CODE: 4644 - MEDICATION REQUIRED - USED TO INDICATE TOPICAL STEROIDS TREATMENT AND NON-STEROIDAL ANTI-INFLAMMATORY MEDICATION. 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. 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 WHO UNDERWENT THE FIRST EYE SURGERY WITH A TECNIS ODYSSEY TORIC SIMPLICITY INTRAOCULAR LENS (IOL) IS NOT RECEIVING THE EXPECTED NEAR VISION POST-OPERATION. THE PATIENT'S VISUAL ACUITY MEASUREMENTS WERE PROVIDED AS DISTANCE VISION (DV): 20/20, PINHOLE (PH): 20/25 -2, NEAR VISION (NV): J8, MANIFEST REFRACTION (MR) +0.25 +0.50 X021 20/25 -1, AND ADD +2.00 J1+. PATIENT STATED HIS DISTANCE VISUAL ACUITY SEEMS PRETTY GOOD BUT EXPERIENCED INTERMITTENT HAZY VISION IN THE OPERATED EYE (OS) AND STRUGGLES WITH NEAR VISION TASKS, HE CANNOT SEE HIS COMPUTER WITH HIS LEFT EYE. NO PAIN OR DISCOMFORT HAS BEEN REPORTED, AND THE PATIENT HAS NOT BEEN USING TEAR DROPS. NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAID) AND STEROID DROPS ARE SCHEDULED AS PART OF THE MEDICAL INTERVENTION. THE SECOND EYE SURGERY FOR RIGHT IS PLANNED FOR ON (B)(6) 2025. THE POSSIBILITY OF EXPLANTING THE LEFT LENS IS BEING CONSIDERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633160 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R