BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 22186704 · Received June 11, 2025

    Report

    Report Number
    3012236936-2025-000163
    Event Type
    Injury
    Date Received
    June 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474813205
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: FEMALE. THE BEST DATE ESTIMATION IS BETWEEN (B)(6) 2025 AND (B)(6) 2025 (IOL IMPLANT AND EXPLANT DATES). 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 RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: 17-JUN-2025. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS RECEIVED IN A PLASTIC BAG WRAPPED IN MEDICAL GAUZE. DURING A VISUAL INSPECTION, THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE AND FIBERS FROM THE MEDICAL GAUZE IT WAS RECEIVED ON. THE LENS WAS CLEANED AND FURTHER INSPECTED, AND DAMAGE ON THE EDGE OF THE LENS WAS OBSERVED. NO FURTHER ISSUES WERE IDENTIFIED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED, THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER (PO) NUMBER. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE DRT375 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF BLURRED VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZLU300 24.5 IOL. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85673 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT375 05050474813205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention