BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 11789499 · Received May 7, 2021

    Report

    Report Number
    3006695864-2021-07641
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    August 19, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 11-JUN-2021. SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. FUNCTIONAL TESTING WAS PERFORMED WITH ALL RESULTS WITHIN SPECIFICATIONS. THE REPORTED ISSUE COULD NOT 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN, NOT PROVIDED. DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED, HOWEVER, BEST ESTIMATE DATE IS (B)(6) 2021 TO (B)(6) 2021. (B)(6). 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 DOCTORS TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTORS TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENTS CORNEA AND THE SUCTION RING. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 THEY EXPERIENCED SUCTION LOSS WITH THE PATIENT INTERFACE (PI) DURING LASER FIRING. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687196 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60243418 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 FEMTO LASER SERIAL NO.(B)(6)