BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FS200

    MDR report key: 6421786 · Received March 21, 2017

    Report

    Report Number
    6421786
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 23, 2017
    Manufacturer
    ALCON
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNEVENTFUL LASIK (B)(6) 2017 OU, ECP EMAILED CD ON 02/11/2017 AM RE STRIAE OD, (B)(6) 2017 SURGEON DID LIFT STRETCH AND REMOVED MINOR INGROWTH. AT (B)(6) 2017 POST-OP, UCVA-20/20 OD. REF MFR #3003288808-2017-00661.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202233 FS200 FS200 OOE ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R