BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3951288 · Received July 22, 2014

    Report

    Report Number
    3006695864-2014-00354
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    IT WAS NOT INCLUDED DURING THE INITIAL REPORT INFECTION/INFLAMMATION. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH RED PAINFUL LEFT EYE WITH CENTRAL CORNEAL INFILTRATE AT ONE WEEK POST TREATMENT. A FLAP LIFT AND RINSE WAS PERFORMED. PATIENT COMPLAINED OF HIS LEFT EYE BEING SWOLLEN SHUT. ACCOUNT REPORTED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). BCVA RIGHT EYE PRE-OP 20/20 POST-OP NOT PROVIDED; BCVA LEFT EYE PRE-OP 20/20 POST-OP 20/CF (COUNTING FINGERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428666 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

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