BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 11771114 · Received May 4, 2021

    Report

    Report Number
    3006695864-2021-07596
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 14, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3 DEVICE EVALUATED BY MANUFACTURER; YES. DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE PATIENT INTERFACE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT 2 ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN RECEIVED. CONCLUSION: BASED ON THE INFORMATION OBTAINED, PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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
    667741 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60280847 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR LASER SERIAL NUMBER: (B)(4)