BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 12823246 · Received November 16, 2021

    Report

    Report Number
    2020664-2021-08042
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 16, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573475
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE FEMTOSECOND LASER SYSTEM WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY A FIELD SERVICE SPECIALIST (FSS). FSS WAS ABLE TO CONFIRM THE ISSUE AND REPAIRS WERE COMPLETED. THE SYSTEM MET JOHNSON & JOHNSON SURGICAL VISION SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VERTICAL GAS BREAKTHROUGH WAS NOTED IN BOTH EYES FOR 1 PATIENT. VGB OCCURRED FOR BOTH EYES ON 1 PATIENT ALMOST IMMEDIATELY AFTER INITIATING THE TREATMENT. THE SURGEON CONTINUED WITH BOTH FLAPS AND TRIED TO LIFT BUT WAS UNABLE TO ENTER THE FLAP BED. PATIENT WAS SENT HOME AND NO FURTHER INFORMATION GIVEN BY CONSULTANT AT THIS TIME. NO OTHER PATIENTS EXPERIENCED ANY ISSUES. SURGEON DOES NOT WANT TO PROVIDE FURTHER INFO REGARDING PATIENT OR ALTERNATIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718956 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007K 05050474573475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other