BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FS200

    MDR report key: 6659944 · Received June 21, 2017

    Report

    Report Number
    6659944
    Event Type
    Injury
    Date Received
    June 21, 2017
    Date of Event
    April 15, 2017
    Report Date
    April 27, 2017
    Manufacturer
    ALCON
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT UNEVENTFUL LASIK OU (B)(6)2017. AT 1 DAY PO FLAP OD WAS WRINKLED. SURGEON NOTIFIED. HE CAME TO CENTER AND FLAP WAS LIFTED AND IRRIGATED. SURGEON ADVISED PT TO FOLLOW UP WITH ECP ON TUESDAY (B)(6) EXTEND LOTEMAX Q2H. CONTINUE FISH OIL. CELLUVISC QHS. ON (B)(6)2017 VASC 20/20 OD, 20/30 OS. REFERENCE MFR # 3003288808-2017-01422.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439914 FS200 FS200 GEX ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R