BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 24242563 · Received February 2, 2026

    Report

    Report Number
    3012236936-2026-000032
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    September 26, 2025
    Report Date
    April 17, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652743
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). 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 AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE 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: MAR 25, 2026. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND LENS WAS CUT INTO FOUR PIECES. NO FURTHER ISSUES WERE IDENTIFIED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A ZFR00V 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 ¿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 PRODUCTION ORDER SHOWS THAT THE UNITS WERE RELEASED WITHIN SPECIFICATIONS. NON CONFORMANCE REPORTS WERE FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE LENS DIOPTER RESULTS SHOW THAT THIS PRODUCTION ORDER WAS RELEASED WITHIN DIOPTER SPECIFICATIONS 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 THE PRELOADED MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED DURING A SECONDARY SURGERY AFTER IMPLANTATION BECAUSE THE PATIENT REPORTED VISUAL DISSATISFACTION RELATED TO IRREGULAR ASTIGMATISM. POSTOPERATIVE VISUAL ACUITY HAD BEEN APPROXIMATELY 0.5¿0.6. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH A NON-JNJ LENS. AFTER THE EXCHANGE, VISUAL ACUITY WAS APPROXIMATELY 0.4; THE PATIENT WAS PRESCRIBED SPECTACLES AND WAS WEARING GLASSES. ADDITIONAL INFORMATION INDICATED THAT PREOPERATIVE ASTIGMATISM WAS CONFIRMED ON ARK AS +5.00D -0.75D × 161. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3628 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention