BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 4346290 · Received October 31, 2014

    Report

    Report Number
    4346290
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ALCON
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT UNEVENTFUL LASIK OU (B)(6) 2014. REFERRED BACK TO CENTER TO EVALUATE STRIAE OD (B)(6) 2014. FLAP WAS LIFTED AND STRETCHED WITHOUT COMPLICATIONS. SEEN (B)(6) 2014 VASC 20/20 OD, 20/20/OS. CORNEAS CLEAR, FLAPS IN PLACE NO STRIAE NOTED AT SLE. CENTER HAS AMO AND ALCON FLAP MARKERS. ORIGINAL INCIDENT HAD THE WRONG FLAP MARKER NOTED. THIS REPORT IS BEING SENT TO THE CORRECT MANUFACTURER. MRF REF #3003288808-2014-01597.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698719 NONE LZS ALCON FS200

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR