BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23088958 · Received September 18, 2025

    Report

    Report Number
    3012236936-2025-000248
    Event Type
    Injury
    Date Received
    September 18, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811461
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: . 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 AND 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: 06-OCT-2025. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE A PIECE OF GAUZE. DURING A VISUAL INSPECTION, THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED CUT INTO THREE PIECES AND COATED IN VISCOELASTIC RESIDUE AND FIBERS FROM THE GAUZE. THE LENS PIECES WERE CLEANED REVEALING THE LENS WAS SCRATCHED. NO FURTHER EVALUATION WAS PERFORMED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER ISSUES OBSERVED DURING PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED; THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. A SEARCH OF COMPLAINTS REVEALED THAT ONE (01) ADDITIONAL COMPLAINT FOLDER WAS FOUND AS PART OF THIS PRODUCTION ORDER (PO) NUMBER ¿ CARTRIDGE CRACK. THESE COMPLAINT ISSUES REPORTED ARE NOT RELATED. BASED ON COMPLAINT HISTORY REVIEW (CHR) RESULTS, NO FURTHER ACTIONS ARE REQUIRED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. POST-OPERATIVELY, THE PATIENT HAD GLARE AND HALOS AT NIGHT DESPITE HAVING GOOD VISION, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 25.0 IOL. REPORTEDLY THERE WAS NO PATIENT ISSUES. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824114 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811461

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention