BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FS30 LASER SYS MOD 3

    MDR report key: 12668764 · Received October 20, 2021

    Report

    Report Number
    2020664-2021-07781
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 20, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN / NOT PROVIDED. INITIAL REPORTER PHONE: (B)(6). FIELD SERVICE SERVICED THE SYSTEM AND REPORTED THAT THE FLAP THICKNESS WAS THINNER THAN EXPECTED. BASELINE, Z SCALE AND Z DRIVER WERE ADJUSTED. A PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED ON THE SYSTEM. SYSTEM MEETS SPECIFICATIONS. REASON(S) FOR CALL OR SITE VISIT AND IF REPORTED PROBLEM(S) CONFIRMED/ 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 SERIAL 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VERTICAL GAS BREAKTHROUGH IN PATIENT'S RIGHT EYE DURING INTRALASE PROCEDURE. THE SURGEON DIDN'T LIFT THE FLAP. THE PATIENT RETURNED AT A LATER DATE AND SURGEON PERFORMED A SURFACE ABLATION AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565167 FS30 LASER SYS MOD 3 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20004K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other