BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23327912 · Received October 17, 2025

    Report

    Report Number
    3012236936-2025-000266
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811331
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. SECTION G4: PMA/510(K) NUMBER: P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: UNKNOWN/NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DOCTOR HAS NO PLANS TO REMOVE THE DEVICE. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD 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 HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE ISSUE WAS IDENTIFIED DURING THE FOLLOW-UP EXAMINATION. THE IOL REMAINS IMPLANTED, AND THE DOCTOR HAS NO PLANS TO REMOVE IT. THERE WAS NO UNPLANNED INCISION ENLARGEMENT AND NO SUTURES. IT IS UNKNOWN IF THERE WAS AN UNPLANNED VITRECTOMY. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S POST-OPERATIVE VISUAL ACUITY OUTCOME IS UNKNOWN. REPORTEDLY, NO OTHER PATIENTS RECEIVED THIS LENS, AND NO OTHER ISSUES WERE REPORTED IN THE OPERATING ROOM. THE PATIENT STATES THAT THE EYE IS SORE AND PAINFUL. VISION IS BAD. THE PATIENT¿S VISUAL OUTCOME WAS REPORTED AS ¿CURRENTLY BEING TREATED.¿ THE FOLLOWING TREATMENT WAS REQUIRED FOR TASS. TOPICAL, SYSTEMIC, AND INTRAOCULAR MEDICATION, NO SUBCONJUNCTIVAL. PRESCRIPTION AND OVER THE COUNTER MEDICATION WAS REQUIRED. THE CUSTOMER DID NOT INDICATE IF THE MEDICATION WAS REQUIRED TO PRECLUDE PERMANENT INJURY AND DOSAGES WERE NOT PROVIDED. NO CULTURE OR PCR (POLYMERASE CHAIN REACTION) WAS PERFORMED. THE CUSTOMER DID NOT OBSERVE A PATTERN IN THEIR CASES AND ON THE DAY OF SURGERY THIS PATIENT WAS #1. THERE WERE NO OTHER SIMILAR INCIDENTS ON THE SAME SURGICAL DAY. THERE WAS NO OTHER JOHNSON AND JOHNSON PRODUCT INVOLVED. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14092 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811331

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention