BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23791592 · Received December 12, 2025

    Report

    Report Number
    3012236936-2025-000313
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    August 25, 2025
    Report Date
    March 11, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811348
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G4: PMA/510(K) NUMBER: P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: JANUARY 12, 2026. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS VISUALLY INSPECTED AND OBSERVED TO BE CUT IN HALF. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE WAS OBSERVED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRT150 MODEL LENS. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED DURING PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, 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

    SECTION A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. 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. ATTEMPTS WERE MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, IMPLANTED IN THE LEFT EYE. POSTOPERATIVELY THE PATIENT EXPERIENCED GLARE DESPITE ADAPTATION MEASURES, INCLUDING THE USE OF MIOTICS. THE SYMPTOMS REMAINED INTOLERABLE, CREATED SAFETY CONCERNS, AND PREVENTED NIGHTTIME DRIVING. AFTER A THOROUGH DISCUSSION OF RISKS, BENEFITS, AND ALTERNATIVES, THE PATIENT ELECTED TO UNDERGO AN IOL EXCHANGE. DURING A SECONDARY PROCEDURE THE ORIGINAL LENS WAS EXPLANTED AND REPLACED WITH AN IOL FROM A DIFFERENT VENDOR (NON¿JOHNSON & JOHNSON). NO UNPLANNED VITRECTOMY OR SUTURES WERE REQUIRED. THE PATIENT¿S OUTCOME WAS GOOD, WITH NO REPORTED INJURY OR COMPLICATIONS SUCH AS A CAPSULAR TEAR. NO FURTHER INFORMATION WAS PROVIDED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759944 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811348

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention