BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4163580 · Received October 10, 2014

    Report

    Report Number
    3006695864-2014-00448
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH CYSTIC EPITHELIAL INGROWTH IN BOTH EYES TWO WEEKS POST TREATMENT. THE FLAP WAS LIFTED AND RINSED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640745 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention WAVELIGHT 1010-3-243