BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23493495 · Received November 6, 2025

    Report

    Report Number
    3012236936-2025-000290
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474827066
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE ACCOUNT DID NOT HAVE THE INFORMATION. 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 PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S RIGHT EYE AND SUBSEQUENTLY REMOVED DUE TO A SCRATCH NEAR THE OPTIC. THE CUSTOMER CONFIRMED THAT THE DAMAGE WAS NOT CAUSED BY USER ERROR. THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) AS A REPLACEMENT. NO PATIENT INJURIES OR COMPLICATIONS, SUCH AS CAPSULE TEAR, UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR THE NEED FOR SUTURES, WERE REQUIRED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. THE LENS IS UNAVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION AS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860648 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474827066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown