BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3980508 · Received August 5, 2014

    Report

    Report Number
    3006695864-2014-00367
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA - ADDED CONCOMITANT PRODUCT, WAVELIGHT SERIAL NUMBER (B)(4). (B)(6 ). (INFLAMMATION). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED THAT PATIENT STILL HAS THE IRITIS AND IS BEING TREATED WITH OCULAR STEROIDS. SHE HAS RESPONDED TO THE STEROIDS BUT WHEN THEY TAPER THE STEROIDS THE IRITIS INCREASES AGAIN. PLACEHOLDER.

    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 IRITIS AND LIGHT SENSITIVITY IN BOTH EYES 2 WEEKS POST TREATMENT. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF DISCOMFORT AND LIGHT SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456324 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention WAVELIGHT SERIAL NUMBER (B)(4)