BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 16854308 · Received May 2, 2023

    Report

    Report Number
    3012236936-2023-00964
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 30, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 AND A5 INFO NOT COLLECTED BY THE COMPLAINT REPORTER. PRODUCT EVALUATION: WAS PERFORMED FOR THIS INCIDENT. NO MALFUNCTIONS WERE FOUND DURING EVALUATION. THE PROBABLE CAUSE IS AN ENVIRONMENTAL ISSUE, NOT EQUIPMENT RELATED. MANUFACTURING ASSESSMENT: MANUFACTURING DEFICIENCY NOT IDENTIFIED. SYSTEM MET ALL SPECIFICATIONS PRIOR TO RELEASE. SERVICE DEFICIENCY NOT IDENTIFIED. DESIGN DEFICIENCY NOT IDENTIFIED, NO APPARENT DESIGN ISSUES. NO USER/USAGE DEFICIENCY IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION H4. DEVICE MANUFACTURE DATE, CHANGED TO 02/28/2020. PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A CASE OF STAGE 3 DIFFUSE LAMELLAR KERATITIS (DLK) IN PATIENT'S BOTH EYES (OU) AFTER THE USE OF THE IFS ADVANCED FEMTOSECOND LASER. AN ORAL STEROID (MEDROL DOSE PACK) WAS PRESCRIBED. TOPICAL STEROID DOSAGE WAS INCREASED. PATIENT'S CHIEF COMPLAINT WAS OF LIGHT SENSITIVITY AND DISCOMFORT. THE EVENT IS NOT LASTING AND DISABLING. PRE-OP BEST CORRECT VISUAL ACUITY WAS; RIGHT EYE (OD) 20/20 3.25 X -1.50 X 0 AND LEFT EYE (OS) 20/20 3.25 X -1.75 X 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143107 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention