BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 10625072 · Received October 5, 2020

    Report

    Report Number
    3006695864-2020-00449
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AND FAILURE OF DEVICE WAS NOT CONFIRMED. THE FSE VERIFIED GAP SEPARATION VIA THE SIDECUT RETRACE CALIBRATION AND OBSERVED THE GAP WAS WELL WITHIN SPECIFICATION THROUGH ENTIRE SIDECUT CURVATURE. 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 INTRALASE FS2 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

    DURING LASER VISION CORRECTION SURGERY, A FLAP CUT ISSUE OCCURRED REQUIRING BANDAGE CONTACT LENS PLACEMENT. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING A UNILATERAL PROCEDURE OF THE RIGHT EYE (OD), THE RASTER BED WAS PERFORMED, HOWEVER THEY WERE NOT ABLE TO DISCERN THE FLAP HINGE. THE FLAP WAS NOT LIFTED, AND THE PHYSICIAN PLACED A BANDAGE CONTACT LENS ON THE TREATED EYE OPTING TO PERFORM PHOTOREFRACTIVE KERATECTOMY (PRK) AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094323 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention