BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5100739 · Received September 24, 2015

    Report

    Report Number
    3006695864-2015-00629
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 24, 2015
    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.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STRIAE IN THE LEFT EYE (OS) AT 5 DAY POST OP EXAM. THE FLAP WAS LIFTED AND STRETCHED TO RESOLVE THE STRIAE REPORTED. POST OP VISUAL ACUITY SANS CORRECTION (VASC) AS OF (B)(6) 2015: 20/15 RIGHT EYE (OD), 20/30 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631236 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention