BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3791384 · Received May 5, 2014

    Report

    Report Number
    3006695864-2014-00266
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 EPITHELIAL MICROCYSTS IN THE RIGHT EYE TWO WEEKS POST TREATMENT. EPITHELIAL DEBRIDEMENT WAS PERFORMED, DURING WHICH FLAP MICROSTRIAE WERE OBSERVED. A FLAP LIFT AND RINSE WAS THEN PERFORMED. TOPICAL STEROID DOSAGE WAS INCREASED. THE PATIENT COMPLAINED ABOUT EXPERIENCING BLURRINESS. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266228 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention WAVELIGHT 1010-3-269