BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILSE FS30 LASERSYSTEM

    MDR report key: 11731829 · Received April 27, 2021

    Report

    Report Number
    3006695864-2021-07577
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 27, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY- UNKNOWN, NOT PROVIDED. EMAIL IS UNKNOWN AS IT WAS NOT PROVIDED. (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE REPLACED THE GALVO BLOCK ASSEMBLY AND THE X/Y DRIVERS, VERIFIED GALVO FUNCTIONS AND OBSERVED MATERIAL IMPROVEMENT IN SIDE-CUT CLARITY AND SYMMETRY. FINALLY, THE ¿SIDE CUT RETRACE CORRECT¿ SOFTWARE SETTING WAS ADJUSTED. THE UNIT MET FACTORY SPECIFICATIONS AT THE CONCLUSION OF SERVICE. 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 ILSE FS30 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 COMPLAINT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING LASER VISION CORRECTION SURGERY, A SIDE CUT ISSUE REQUIRING BANDAGE CONTACT LENS (BCL) PLACEMENT OCCURRED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE PROCEDURE ON (B)(6) 2021, THE SURGEON EXPERIENCED A ROUGH SIDE CUT ON THE EPITHELIAL SIDE. A BCL WAS PLACED ON A PATIENT FOR COMFORT. THE SURGEON DID NOT INDICATE THE CURRENT STATE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628377 ILSE FS30 LASERSYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention