BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 12853853 · Received November 22, 2021

    Report

    Report Number
    3012236936-2021-00054
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    September 30, 2021
    Report Date
    January 1, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES . RETURNED TO MANUFACTURER: YES. DATE RETURNED TO MANUFACTURER: NOVEMBER 9, 2021. SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: ONE OPENED PI WAS RECEIVED WITHIN ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. NOTE: THIS REPORT IS BEING SUBMITTED ON JANUARY 1, 2022 LOCAL PACIFIC STANDARD TIME. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY EXPERIENCED SUCTION LOSS WITH THE PATIENT INTERFACE 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
    1751435 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60218187 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown