BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 21037077 · Received December 30, 2024

    Report

    Report Number
    3012236936-2024-000348
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    November 20, 2024
    Report Date
    February 21, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: DURING A SERVICE TO CHECK THIS SYSTEM DUE TO A THE REPORTED ISSUE, THE SERVICE ENGINEER FOUND THE MAX ENERGY WAS TOO LOW AND REPLACED THE AMPLIFIER (AMP) GLASS. IN ADDITION, THE SERVICE ALSO COMPLETED A PM (PREVENTIVE MAINTENANCE). THE SYSTEM WAS CHECKED AND IS WORKING WITHIN JOHNSON & JOHNSON SURGICAL VISION (JJSV) SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE MACHINE IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE MACHINE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED SITE TO SERVICE THE SYSTEM AND CARRIED OUT A FULL SYSTEM CHECK TO INVESTIGATE THE DIFFUSE LAMELLAR KERATITIS (DLK) ISSUE. CHECKED SYSTEM PERFORMANCE. SYSTEM MEETS JOHNSON AND JOHNSON VISION SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: IN THE INITIAL REPORT THE FOLLOWING CODE WAS NOT ADDED: SECTION H6 -HEALTH EFFECT - IMPACT CODE: 4644 - MEDICATION REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN NUMBER OF PATIENTS EXPERIENCED HIGH GRADE DLK AND AT 1 DAY POST PROCEDURE, THE PATIENTS UNDERWENT A FLAP LIFT AND CLEAN WHICH RESOLVED THE DLK. ROUTINE POST OP MEDS PRESCRIBED WERE, OFTAQUIX, PRED FORTE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420818 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention