BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22959366 · Received September 3, 2025

    Report

    Report Number
    3012236936-2025-000231
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Report Date
    November 4, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810815
    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

    SECTION A2 (AGE), A3B, A4, A5 AND A6: UNKNOWN; INFORMATION NOT PROVIDED. SECTION E1: EMAIL ADDRESS: UNKNOWN, INFORMATION 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 THE DEVICE HISTORY RECORD, COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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: SEPTEMBER 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 HALVES WERE CLEANED REVEALING THAT 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 THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND FURTHER ESCALATIONS ARE REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. 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 HAD A TECNIS ODYSSEY SIMPLICITY 22.0D INTRAOCULAR LENS (IOL) IMPLANTED ON (B)(6) 2025 IN THE LEFT EYE (OS). PATIENT PRESENTED POST OP WITH HYPEROPIC SURPRISE AND LENS WAS EXPLANTED ON (B)(6) 2025. DURING EXPLANT PROCEDURE, A DIFFERENT MODEL, THE OPTIBLUE EXTENDED DEPTH OF FOCUS (EDOF) 23.0D LENS, WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL MEDICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386935 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention