BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 1326865 · Received February 24, 2009

    Report

    Report Number
    3006695864-2009-00006
    Event Type
    Injury
    Date Received
    February 24, 2009
    Date of Event
    December 12, 2008
    Report Date
    February 13, 2009
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    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

    ON 01/07/2009 A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND PERFORMED A PREVENTIVE MAINTENANCE (PM). DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. A CLINICAL DEVELOPMENT SPECIALIST (CDS) VISITED THE SITE AND PERFORMED AN INVESTIGATION IN ATTEMPT TO IDENTIFY A POTENTIAL ROOT CAUSE FOR DLK. THE CDS ASSESSED THE PHYSICIAN'S ENVIRONMENTAL FACTORS AND STERILITY PROCESS. ALTHOUGH A SINGLE ROOT CAUSE WAS NOT IDENTIFIED; THE SITE REPLACED THE ORIGINAL STERILIZER WITH A NEW STERILIZER. SINCE THE IMPLEMENTATION OF THE NEW STERILIZER THE SITE HAS NOT HAD ANY REPORT OF DLK CASES. IT SHOULD BE NOTED THAT THE AMERICAN ACADEMY OF OPHTHALMOLOGY (AAO) RECOMMENDS TREATING STAGES 1 & 2 DLK WITH TOPICAL STEROIDS AND OBSERVATION. THE AAO DOES NOT RECOMMEND PERFORMING A FLAP LIFT & RINSE AT THESE MILD STAGES. THE PHYSICIAN DID NOT FOLLOW THE RECOMMENDED TREATMENT PROTOCOL. WHEN THE ORIGINAL STERILIZER WAS IN PLACE, DLK APPEARED. ORIGINAL STERILIZER HAS BEEN REPLACED.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE A BILATERAL CORNEAL FLAP(S) FOR LASIK SURGERY IN 2008. ONE DAY POSTOPERATIVELY, THE PATIENT PRESENTED WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK) ON BOTH (OU) EYES. A FLAP LIFT AND RINSE WAS PERFORMED. PATIENT WAS TREATED WITH ORAL AND TOPICAL STEROIDS. THE PATIENT'S PREOPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 OU. PATIENT'S POSTOPERATIVE BCVA IS 20/20 OU AS OF 2009. THE PATIENT RESPONDED TO TREATMENT AND DLK HAS RESOLVED. THE ASSOCATION BETWEEN THE EVENT AND THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER HNO AMO MANUFACTURING USA, LLC. 20005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention