BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 23661450 · Received November 26, 2025

    Report

    Report Number
    3012236936-2025-000313
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    August 22, 2025
    Report Date
    January 3, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS DETERMINED THAT SECTION H4 DEVICE MANUFACTURE DATE IN THE INITIAL MDR REPORTED, THE INCORRECT DATE WAS INADVERTENTLY PROVIDED. THE CORRECT DATE IS 08/09/1999. THEREFORE, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECT DATA. ADDITIONAL INFORMATION: PRODUCT EVALUATION WAS PERFORMED FOR THIS INCIDENT. NO MALFUNCTION WAS DETERMINED, THE DEVICE DID NOT FUNCTION AS INTENDED BUT ONLY REQUIRED MINOR ADJUSTMENTS OR CALIBRATIONS. USER SETTINGS REQUIRED CALIBRATION. OUR FIELD SERVICE ENGINEER ALIGNED AMPLIFIERS. ASSESSMENTS OF MANUFACTURING, SERVICE, DESIGN, AND USAGE WERE COMPLETED, AND THE SYSTEM IS PERFORMING TO SPECIFICATION AFTER THE AMPLIFIERS WERE ALIGNED. REVIEWS OF LABELING AND RISK MANAGEMENT FILES WERE CONDUCTED, AND NO NEW ISSUES/RISKS WERE IDENTIFIED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. THE REPORTED ISSUE IS AN ANTICIPATED/EXPECTED EVENT FOR THE SYSTEM AND DOES NOT REPRESENT A NEW RISK. BASED ON THE LAST ANNUAL RISK MANAGEMENT REVIEW AND ONGOING POST-MARKET SURVEILLANCE ACTIVITIES, THE PROBABILITY OF OCCURRENCE FOR THE REPORTED EVENT REMAINS WITHIN THE RATES ESTABLISHED IN THE PRODUCT RISK MANAGEMENT FILES. A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 TELEPHONE NUMBER, (B)(6). SECTION H3: OUR FIELD SERVICE ENGINEER (FSE) WAS ONSITE FOR A SYSTEM EVALUATION. FLAP THICKNESS CONFIRMED TO BE WITHIN SPECIFICATIONS. FLAP QUALITY REPAIR COMPLETE. PREVENTIVE MAINTENANCE COMPLETE. NO OTHER ISSUE OR COMPLAINT OBSERVATIONS HAVE BEEN MADE. SYSTEM CONFORMS TO ALL J&J SPECIFICATIONS. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED SIGNIFICANT VERTICAL GAS BREAKTHROUGH WITH A THINNER FLAP (95 MICRONS) FLAP WITH POCKET TURNED OFF; IT HAPPENED IN MULTIPLE AREAS DURING THE LAST 1/2 OF THE CUT, NO SUCTION LOSS, SURGERY WAS ABORTED. DOCTOR STATES PATIENT IS DOING OK AND IS FULLY RECOVERED. PATIENT WAS NOT PRESCRIBED MEDICATION (OUTSIDE OF STANDARD OF CARE). BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE: 20/20. BEST CORRECTED VISUAL ACUITY (BSCVA) POST-OPERATIVE: 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735776 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other