BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 17317399 · Received July 13, 2023

    Report

    Report Number
    3012236936-2023-01633
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 14, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION : THE FOLLOWING INFORMATION WAS AVAILABLE AND INADVERTENTLY NOT INCLUDED WHEN INITIAL REPORT WAS SUBMITTED: THE FIELD SERVICE ENGINEER (FSE) VISITED THE ACCOUNT TO EVALUATE THE SYSTEM. SEVERAL CHECKS WERE CARRIED OUT AND A PREVENTIVE MAINTENANCE WAS PERFORMED . NO MALFUNCTIONS WERE FOUND DURING THE EVALUATION AND THE SYSTEM MET ALL JOHNSON AND JOHNSON VISION SPECIFICATIONS. ADDITIONAL INFORMATION: SECTION H4 - DEVICE MANUFACTURE DATE: 10/30/2006. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - (81): THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: STEROID RESPONDER : INTRAOCULAR PRESSURE INCREASE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) THAT WHEN VISITING THE SITE, A VERTICAL GAS BREAKTHROUGH OCCURRED ON THE LAST PATIENT OF THE DAY WHEN USING THE SYSTEM. THROUGH FOLLOW-UP WE LEARNED THAT THE PROCEDURE WAS STOPPED AND THE PATIENT WAS ESCORTED TO THE SURGEONS ROOM TO EXPLAIN THE RISK OF A BUTTON HOLE FLAP. THEY DISPENSED THE PATIENT WITH ANTIBIOTICS AND ANTI INFLAMMATORY MEDICATION WAS PRESCRIBED 4X DAILY FOR 1 WEEK. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT HAD A FOLLOW UP ON THE (B)(6) 2023 AND THEY STOPPED THE STEROID RESPONDER TO ALLOW MORE TIME TO SETTLE AND REVIEW IN 3 WEEKS TO SCHEDULE THE PATIENT FOR A BILATERAL LASEK PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170604 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention