BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21451108 · Received February 24, 2025

    Report

    Report Number
    3012236936-2025-000054
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    July 23, 2024
    Report Date
    February 24, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474764163
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3(NO): 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, AND RISK DOCUMENTATION FOR THIS DEVICE 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 - IMPACT CODE: 4625 - SUTURES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) IN A SECONDARY SURGICAL PROCEDURE DUE TO MULTIFOCAL INTOLERANCE. THE PATIENT COMPLAINED OF SYMPTOMS OF CLOUDY VISION AND REPORTEDLY WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES POST CATARACT SURGERY. A MONOFOCAL LENS OF HIGHER DIOPTER (MODEL DCB00, 21.0D) WAS USED AS A REPLACEMENT. DURING IOL EXCHANGE, OLD INCISION OPENED NEXT TO CURRENT AND MADE ONE (1) BIG INCISION REQUIRING TWO (2) TEMP SUTURES AT INCISION. IT WAS CLARIFIED THAT THE SUTURES WERE NOT DUE TO AN INJURY, THE OLD INCISION OPENED UP TO A FOUR (4) MM INCISION, WHICH REQUIRED TWO (2) SUTURES. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT'S POST-OP STATUS WAS REPORTED AS VISUAL ACUITY (VA) IN OS BLURRY, FOREIGN BODY (FB) SENSATION. IT WAS NOTED THAT THE EXPLANTED DEVICE WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST LENS MENTIONED (ORIGINAL LENS THAT WAS EXPLANTED). NO REPORT WILL BE FILED AGAINST THE REPLACEMENT LENS AS THE EVENT DOES NOT MEET REPORTABILITY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413251 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DXW225 05050474764163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention