BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 12422370 · Received September 3, 2021

    Report

    Report Number
    2020664-2021-07307
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 3, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT,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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS ATTEMPTING TO CREATE FLAPS AND SUCTION BROKE AFTER THE LASER FIRED ON THE LEFT EYE (OS) WITH ONE SECOND INTO THE TREATMENT USING A PATIENT INTERFACE. SURGEON ELECTED TO ABORT TREATMENT AND HAVE PATIENT RETURN IN A WEEK. THEY ATTEMPTED A SECOND PROCEDURE ON (B)(6) 2021 BUT WERE UNABLE TO GET THE SUCTION TO HOLD. SUCTION BREAK WAS PRIOR TO THE RASTER PATTERN AND THE SURGEON CONVERTED TO PHOTOREFRACTIVE KERATECTOMY (PRK). PRE OP BEST CORRECTED VISUAL ACUITY (BCVA) OS: 20/20-1. AT ONE WEEK POST POST-OP PATIENT IS SEEING 20/50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320197 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60290828 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention FEMTO LASER SN # (B)(4)