BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 5101139 · Received September 24, 2015

    Report

    Report Number
    3006695864-2015-00635
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    July 30, 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

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #:(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 EXPERIENCED PAIN ON RIGHT EYE (OD) TWO HOURS AFTER BEING DISCHARGED. THE PATIENT RETURNED TO THE SURGERY CENTER AND A SLIPPED FLAP WAS NOTED OD. THE PATIENT WAS TAKEN BACK TO THE LASER SUITE AND THE FLAP WAS REPOSITIONED. POST OP VISUAL ACUITY SANS CORRECTION (VASC) AS OF (B)(6) 2015: 20/20 OD, 20/20 LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631290 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention