BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 22815168 · Received August 15, 2025

    Report

    Report Number
    3012236936-2025-000218
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 15, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474575646
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: TITLE, EMAIL ADDRESS, CITY, STATE, POST OFFICE OR ZIP CODE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION, THE LENS UNFOLDED SLOWLY, AND THE POSTERIOR LENS REMAINED IN THE SEMI-UNFOLDED STATE. DOCTOR HAD TO SURGICALLY INTERVENE AND ADJUST OF THE LENS POSITION. THE DOCTOR ACCIDENTALLY SCRAPED THE ANTERIOR CAPSULE AT THE OPTIC EDGE AND HAPTIC OF THE LENS, RESULTING IN THE RUPTURE OF THE ANTERIOR CAPSULE IN THE PATIENT. SUTURES WERE PERFORMED. UNDER THE MICROSCOPE, IT IS RELATIVELY CLEAR THAT THE EDGE OF OPTIC HAPTIC WAS DAMAGED. DELAY TO OVERALL PROCEDURE SURGERY TIME. IOL REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2687868 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 05050474575646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention