BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO

    MDR report key: 9595312 · Received January 16, 2020

    Report

    Report Number
    3005643720-2020-00001
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    November 23, 2019
    Report Date
    January 15, 2020
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    HQF
    PMA / PMN Number
    K112154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LASIK OU (B)(6) 2019. DEVELOPED DLK OD, STEROID PF INCREASED TO QHR OD. FLAP LIFT (B)(6) 2019 OD. (B)(6) 2019 PO VASC 20/40 OD, 20/20 OS. RXM OD NO IMPROVEMENT. WILL CONTINUE TO MONITOR AS EPI REMODELS. AR APPROX +2.50 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62098 FEMTO FEMTO LDV Z4 HQF SIE AG, SURGICAL INSTRUMENT ENGINEERING FEMTO Z4 PP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention