BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4035367 · Received August 25, 2014

    Report

    Report Number
    3006695864-2014-00395
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PATIENT SEEN ON (B)(6) 2014 VASC (VISUAL ACUITY SANS CORRECTED) 20/20 RIGHT AND 20/25+2 LEFT EYE, DOING WELL. THIS INFORMATION WAS AVAILABLE AT THE TIME OR THE INITIAL REPORT BUT WAS NOT INCLUDED. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED PATIENT UNDERWENT UNEVENTFUL ILASIK (B)(6) 2014. PRESENTED AT 1 DAY POST OP WITH STRIAE IN LEFT EYE. VISUAL ACUITY SANS CORRECTED (VASC) 20/25 RIGHT EYE, 20/40 LEFT EYE. LEFT EYE FLAP LIFTED AND STRETCHED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513641 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention