BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 22999865 · Received September 9, 2025

    Report

    Report Number
    3012236936-2025-000238
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    May 29, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811232
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: THE 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 WILL BE FILED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137- BLURRED VISION- USED TO INDICATE BLURRED VISION AND POOR NEAR VISION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: SEP 30, 2025 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE LENS WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED AND NO ISSUES WERE IDENTIFIED. NO FURTHER EVALUATION WAS PERFORMED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS REVIEW FOR THIS PO SHOWS THAT THE UNITS WERE RELEASED WITHIN SPECIFICATION. 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 A PATIENT UNDERWENT AN ODYSSEY TORIC INTRAOCULAR LENS (IOL) EXCHANGE DUE TO DISSATISFACTION WITH NEAR/INTERMEDIATE VISION AND FELT THAT SHE COULD NOT READ WELL DESPITE A QUALITATIVE OUTCOME. THE ORIGINAL LENS WAS REPLACED WITH NON-J&J LENS. THE AFFECTED EYE WAS THE LEFT EYE (OS). PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/40 AND 20/50. POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY 1 DAY POST-OP IOL EXCHANGE WAS 20/30-2, J1. POST-EXCHANGE, THE PATIENT¿S UNCORRECTED AND BEST-CORRECTED VISUAL ACUITY IMPROVED FROM J2 PRE-EXCHANGE TO J1 ON POST-OP DAY 1. NO PATIENT INJURY OR DEBILITATING CONDITION. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE NOT REQUIRED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258448 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention