BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 12380548 · Received August 27, 2021

    Report

    Report Number
    2020664-2021-07257
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    July 29, 2021
    Report Date
    October 7, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B1 REPORT TYPE: IN THE INITIAL REPORT IT WAS REPORTED AS AN ADVERSE EVENT AND PRODUCT PROBLEM HOWEVER, IT SHOULD ONLY HAVE BEEN A PRODUCT PROBLEM. B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: IN THE INITIAL REPORT, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) WAS REPORTED. THIS INFORMATION HAS BEEN REMOVED AS THERE WAS NO SERIOUS INJURY AND PHOTOREFRACTIVE KERATECTOMY (PRK) WAS NOT PERFORMED. H1 TYPE OF REPORTABLE EVENT: IN THE INITIAL REPORT IT WAS, SERIOUS INJURY WAS REPORTED. THIS HAS BEEN UPDATE TO MALFUNCTION. ADDITIONAL INFORMATION: B5: DESCRIPTION OF EVENT: (B)(6) 2021 ADDITIONAL INFORMATION WAS RECEIVED BY APPLICATION SUPPORT MANAGER. PRE OP VISION WITH REFRACTIVE CORRECTION (CC): RIGHT (OD) EYE WAS 20/25. LEFT (OS) EYE WAS 20/25. WITHOUT REFRACTIVE CORRECTION (SC): RIGHT (OD) EYE WAS CF4FT. LEFT (OS) EYE WAS CF4FT. POST-OP VISION WITH REFRACTIVE CORRECTION (CC): RIGHT (OD) EYE 20/25+2. LEFT (OS) EYE 20/25+2. THE PATIENT DECIDED NOT TO PROCEED WITH ANY FURTHER SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT MEDRA CODE (B)(4) FLAP ISSUES: DIFFICULT LIFT. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE WENT TO THE CUSTOMER SITE TO EVALUATE AND REPAIR CAUSE OF 514 BEAM STEERING ERROR WHICH WAS CONFIRMED ERROR IN LOG. THE FSE VIEWED BEAM IN SERVICE APPLICATION AND NOTED BEAM TO BE VERY BRIGHT IN BEAM STEERING CAMERA VIEW DETERMINING FILTER OPTIC TO BE BURNED THROUGH. THE FILTER OPTICS WERE REPLACED AND VERIFIED THE DELIVERY ALIGNMENT. BEAM SHAPE AND INTENSITY ARE NOW CORRECT. SYSTEM MEETS SPECIFICATIONS. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR FEMTOSECOND LASER SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMTO SYSTEM PRODUCED A BEAM STEERING ERROR DURING PROCEDURE PRIOR TO SIDECUT. THE FLAP WAS INCOMPLETE AND WOULD NOT LIFT. IT WAS STATED THAT THE SURGEON WILL ALLOW FLAP TO HEAL AND DO PHOTOREFRACTIVE KERATECTOMY (PRK) AT A LATER DATE TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274689 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Other