BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22552172 · Received July 20, 2025

    Report

    Report Number
    3012236936-2025-000198
    Event Type
    Injury
    Date Received
    July 20, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 8, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655379
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AFTER A THOROUGH REVIEW, IT WAS FOUND THAT THE COMPLAINT WAS ALSO FILED UNDER REPORT NUMBER 3012236936-2025-0001896. THIS REPORT WITH MFR REPORT NUMBER 3012236936-2025-0001984 IS CONSIDERED A DUPLICATE. HENCE, A CORRECTION MDR IS REQUIRED, WITH THE AWARENESS DATE SET FOR 8/11/2025, WHICH IS THE DATE THE FILE UNDERWENT REVIEW. THEREFORE, THIS FOLLOW-UP #1 IS BEING SUBMITTED TO PROVIDE THE CORRECTED DATA. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2025-0001984. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN; INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED AND REPLACED IN SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED AND REPLACED IN SAME PROCEDURE. SECTION E1: TITLE, EMAIL ADDRESS: 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 BY THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, A LENS WAS IMPLANTED IN A PATIENT'S EYE, BUT A BLACK MARK WAS OBSERVED IN THE CENTER OF THE LENS. AS A RESULT, THE LENS HAD TO BE CUT OUT, AND A BACKUP LENS WAS USED. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE EVENT OCCURRED DURING THE IMPLANTATION PROCESS, AND THE PATIENT WAS NOT PERMANENTLY OR TEMPORARILY IMPAIRED, WITH THEIR STATUS MARKED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784947 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown