BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23576343 · Received November 17, 2025

    Report

    Report Number
    3012236936-2025-000303
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    August 8, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811195
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: 11-DEC-2025. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE A BIOHAZARD BAG WITH TWO SWABS. A "GUIDE TO SHIPPING JJSV CUSTOMER RETURNS" IDENTIFYING THE COMPLAINT PRODUCT SERIAL NUMBER WAS ALSO RECEIVED. DURING A VISUAL INSPECTION, THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE; ONE HAPTIC WAS DETACHED. THE LENS HALVES WERE CLEANED REVEALING NO FURTHER ISSUES. THE PHYSICAL CHARACTERISTICS OF THE RECEIVED LENS WAS CONFIRMED TO MATCH THAT OF A DRT150 MODEL LENS. 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 THE 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 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 COULD BE IDENTIFIED. 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 A-3B PATIENT GENDER: MALE 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. SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 2140 ¿ GLARE AND VISUAL DISTURBANCE ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT REPORTED ALL LETTERS/WORDS HAVE A SHADOW AURA AROUND THEM, DISTANCE AND NEAR VISION ARE NOT CLEAR, DIFFICULTY READING, HALOS AROUND LIGHTS, AND DIFFICULTY WITH GLARE. VISION PRE-OPERATIVE WAS 20/50 AND POST-OPERATIVELY WAS 20/60-2. THUS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 12.0 DIOPTER IOL. THERE WAS NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE HOWEVER IT IS UNKNOWN IF THE INCISION WAS ENLARGED OR IF SUTURES WERE REQUIRED. MEDICAL ATTENTION WAS REQUIRED AND PREDNISOLONE ACETATE MEDICATION WAS PRESCRIBED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326645 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811195

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention