BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 4806273 · Received May 29, 2015

    Report

    Report Number
    3006695864-2015-00240
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH DRY EYE ON THE BOTH (OU) EYES AT A 2 YEAR POST-OPERATIVE EXAM. THE SURGERY CENTER DESCRIBED A LONGSTANDING DRY EYE SINCE PROCEDURE. PUNCTAL PLUGS WERE USED FOR BOTH EYES. THE PATIENT COMMENTED THAT EYES WERE DRY SINCE PROCEDURE AND ARTIFICIAL TEARS AND RESTASIS DID NOT HELP. THE PATIENT STATED THE TEMPORARY PLUGS HELPED. PRE-OPERATIVE MEASUREMENTS DATE: (B)(6) 2013: BCVA 20/20 OD, 20/20 OS, SPHERE 2.00 OD, 1.50 OS, CYLINDER -1.00 OD, -.75 OS, AXIS 85 OD, 89 OS. POST-OPERATIVE MEASUREMENTS DATE: (B)(6) 2013: BCVA 20/25 OD, 20/25 OS, SPHERE .00 OD, .00 OS, CYLINDER -.50 OD, -.25 OS, AXIS 135 OD, 0 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349638 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other WAVELIGHT SERIAL NO. (B)(4)