BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23764718 · Received December 9, 2025

    Report

    Report Number
    3012236936-2025-000305
    Event Type
    Injury
    Date Received
    December 9, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474813007
    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: 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

    ADDITIONAL INFORMATION: SECTION A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION B3, DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE BEST ESTIMATE IS BETWEEN THE IMPLANT AND EXPLANT DATE (B)(6) 2025, THROUGH (B)(6) 2025. 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 RIGHT EYE. DURING A POST-OPERATIVE EXAMINATION THE PATIENT REPORTED REALLY STRUGGLING WITH READING THEIR PHONE AND RECIPES AND STILL HAVING TO USE READERS OFTEN. SHE HAS TO GO RIGHT UP TO THE STREET SIGNS TO SEE THEM. THE PATIENT THOUGHT SHE WOULD SEE BETTER THAN THIS. REPORTEDLY, THE PATIENT¿S DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED. THEIR PRE-OPERATIVE VISION WAS REPORTED AS 20/30 -2. THEIR POST-OPERATIVE VISION AND PATIENT STATUS WAS REPORTED AS UNKNOWN. THE IOL WAS EXPLANTED. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. FOLLOW-UP WAS PERFORMED TO GET MORE DETAILS REGARDING THE REPORTED EVENT BUT THE CUSTOMER EXPLAINED THAT WITHOUT THE PATIENT¿S DATE OF BIRTH IT WILL BE DIFFICULT TO LOCATE THIS CASE. THEY WILL CALL US BACK IF THEY FIND ADDITIONAL INFORMATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878547 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT375 05050474813007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention