BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 11738114 · Received April 28, 2021

    Report

    Report Number
    3006695864-2021-07579
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 5, 2021
    Report Date
    July 1, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES , RETURNED TO MANUFACTURER ON 12 APR, 2021. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED, AND NO OBVIOUS DAMAGE/DEFECT WAS OBSERVED. SUCTION TEST WAS PERFORMED, AND ALL RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT CANNOT BE CONFIRMED. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, LOT HISTORY, AND TRENDING WERE 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 THE PATIENT INTERFACE SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN/ NOT PROVIDED. REPORTER EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AT THIS TIME. DEVICE MANUFACTURE DATE: UNKNOWN AT THIS TIME. DEVICE EVALUATED BY MFR: THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT PATIENT INTERFACE HAD SUCTION LOSS DURING LASER FIRING. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635874 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60247738

    Patients

    Seq Age Sex Outcome Treatment
    1 LASER SERIAL NUMBER: (B)(4)