BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 18994827 · Received March 28, 2024

    Report

    Report Number
    3012236936-2024-00991
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 27, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: REQUESTED BUT WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LASER SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LASER SYSTEM IS NOT AN IMPLANTABLE DEVICE. AN APPLICATION SUPPORT MANAGER WAS ONSITE DURING THE PROCEDURE, AND THAT THE SYSTEM WAS PERFORMING AS INTENDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER HAD A SMALL VERTICAL GAS BREAKTHROUGH INFERONASAL TO THE PUPIL RIGHT EYE ON THEIR LAST PATIENT OF THE DAY. DOCTOR LIFTED THE FLAP AND COMPLETED THE LASIK PROCEDURE WITHOUT ISSUE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028927 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other