BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 11793610 · Received May 7, 2021

    Report

    Report Number
    3006695864-2021-07557
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    October 25, 2020
    Report Date
    July 1, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - UPDATED. SECTION H: RETURNED PI INVESTIGATION. THE PATIENT INTERFACE WAS RECEIVED WITH COMPONENTS LOOSE WITHIN THE PACKAGE, UNABLE TO BE ASSOCIATED WITH THEIR CORRESPONDING LOT, COMPLAINT FILE, OR PRODUCT INVESTIGATION RECORD NUMBERS. PRODUCT EVALUATION COULD NOT BE PERFORMED. A SEARCH FOR RELATED COMPLAINTS FROM THE LOT NUMBER FROM THE LAST 12 MONTHS WAS CONDUCTED. NO RELATED COMPLAINTS WERE FOUND. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE PI 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 INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. 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. 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 THE 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
    685937 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60155493 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 FEMTOSECOND LASER SN: (B)(6)