BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 21657475 · Received March 20, 2025

    Report

    Report Number
    3012236936-2025-000080
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 25, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474813168
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: FEMALE. SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-5 PATIENT ETHNICITY: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-6 PATIENT RACE: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. 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 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 REPORT WILL BE FILED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. 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

    WHEN SURGEON TRIED TO INSERT THE PRE-LOADED DRT375 MODEL INTRAOCULAR LENS (IOL), THE INSERTER DID NOT FIT INTO THE 2.4MM WOUND, AND THE INCISION WAS ENLARGED. THE DOCTOR THEN PROCEEDED TO TURN THE KNOB AND FELT HEAVY RESISTANCE. AFTER LENS INSERTION, MULTIPLE SCRATCHES WERE OBSERVED IN THE CENTER AND PERIPHERY OF THE LENS. ABOUT TWO (02) HOURS LATER THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER DRT375 22.0 DIOPTER IOL THAT WAS OBTAINED FROM ANOTHER FACILITY. THERE WAS NO SUTURES AND NO VITRECTOMY. PATIENT STATUS POST PROCEDURE WAS REPORTED AS FULLY RECOVERED. IT WAS REPORTED THE SURGICAL TECHNICIAN LOADING THE LENS HAS USED THIS INSERTER BEFORE. WHEN REVIEWING HE CONFIRMED THAT HE DID NOT OVERFILL INTO THE LENS CASE DURING HYDRATION. THE KNOB WAS TURNED MORE THAN HALF A ROTATION, PUSHING THE LENS TO THE TIP. SALES REP INFORMED HIM THAT HE NEEDS TO ONLY TURN A HALF ROTATION. BOTH BSS & OVD WERE USED. IT WAS INDICATED THE IOL DIRECTION FOR USE WERE NOT FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476520 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT375 05050474813168

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention