BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 764753 · Received September 25, 2006

    Report

    Report Number
    2032002-2006-00054
    Event Type
    Injury
    Date Received
    September 25, 2006
    Date of Event
    August 5, 2006
    Report Date
    August 6, 2006
    Manufacturer
    INTRA LASE CORP.
    Product Code
    HQF
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTRALASE CLINICAL APPLICATIONS SPECIALIST (CAS) VISITED THE SITE ON 08/24/06 AND THE DEVICE MET SPECIFICATIONS AND WAS PERFORMING AS INTENDED. IN ADDITION, AN INTRALASE FIELD SERVICE ENGINEER EVALUATED THE LASER ON 08/30/06 AND ADJUSTED FLAP SETTINGS. THE LASER MET SPECIFICATIONS AND WAS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE A CORNEAL FLAP FOR BILATERAL LASIK SURGERY IN 2006. ONE-DAY POSTOPERATIVELY THE PT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (8/5/06) THE PT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN THE BOTH EYES (OU). A FLAP LIFT AND RINSE WAS PERFORMED OU. THE PT'S PREOPERATIVE BCVA WAS 20/20 OU; POSTOPERATIVE BCVA IS CURRENTLY 20/20 OD AND 20/40-1 OS (CORRECTED FOR MONOVISION). THE PT RESPONDED TO TREATMENT AND THE DLK RESOLVED. THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER LASER KERATOME HQF INTRA LASE CORP. 20003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention