BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FSI LASER

    MDR report key: 1931602 · Received December 10, 2010

    Report

    Report Number
    3006695864-2010-00140
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: JOURNAL OF CATARACT AND REFRACTIVE SURGERY 2010; 36: 1912-1918. (TABLE 4, STAGE AND TIME TO RESOLUTION IN DLK CASES). (B)(4) (DIFFUSE LAMELLAR KERATITIS - DLK). EQUIPMENT HAS NOT BEEN IDENTIFIED. INVESTIGATION IS BEING CONDUCTED TO IDENTIFY THE EQUIPMENT.

    Description of Event or Problem · 1

    INCIDENCE OF DLK STAGE III AFTER LASIK WITH 15 KHZ FEMTOSECOND LASER FLAP CREATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FSI LASER HNO AMO MANUFACTURING USA LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other