BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 1338126 · Received March 4, 2009

    Report

    Report Number
    3006695864-2009-00009
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 5, 2009
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MANUFACTURE DATE: 02/2005. LASER INVOLVED AT THE TIME OF THE ISSUE WAS NOT IDENTIFIED BY THE SITE. SITE HAD TWO WORKING LASERS. EVALUATION SUMMARY: IN 2008, A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE DEVICE. DEVICE MET SPECIFICATIONS AND PERFORMED AS INTENDED. LASER WAS DE-INSTALLED IN EARLY 2009 - CUSTOMER HAD NOT RENEWED SERVICE AGREEMENT AND NO LONGER REQUIRED A SECOND LASER. TWO WEEKS LATER, AN FSE VISITED THE SITE AND PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE DEVICE. DEVICE MET SPECIFICATIONS AND PERFORMED AS INTENDED. THE FOLLOWING MONTH, AN FSE INSPECTED THE LASER AND FOUND IT TO BE WITHIN AMO SPECIFICATIONS. ON THE DAY PRIOR, A CLINICAL DEVELOPMENT SPECIALIST (CDS) VISITED THE SITE AND PERFORMED AN INVESTIGATION IN AN ATTEMPT TO IDENTIFY A POTENTIAL ROOT CAUSE FOR DLK. THE SITE HAD RECENTLY REPLACED THEIR ORIGINAL STERILIZERS WITH NEW STERILIZERS. SINCE THE IMPLEMENTATION OF THE NEW STERILIZERS THE SEVERITY OF THE DLK HAS DECREASED AND THEY HAVE SEEN A REDUCTION IN DLK CASES. WHILE ON SITE, THE CDS MODIFIED THE SURGEON'S LASER SETTINGS, ASSESSED THE PHYSICIANS ENVIRONMENTAL FACTORS, STERILITY PROCESS AND VERIFIED SURGEONS SURGICAL TECHNIQUE HAD NOT CHANGED. ALTHOUGH A SINGLE ROOT CAUSE WAS NOT IDENTIFIED, THE SITE WAS ADVISED AND HAS AGREED TO CONTINUE TO MONITOR THE SITE'S HEATING, AIR CONDITIONING, SURGICAL INSTRUMENT PREPARATION AND STERILIZATION TECHNIQUE AND THE NUMBER OF PEOPLE IN THE SURGICAL SUITE AT ONCE DURING SURGERY. IT SHOULD BE NOTED THAT THE AMERICAN ACADEMY OF OPHTHALMOLOGY (AAO) RECOMMENDS TREATING STAGES 1 AND 2 WITH TOPICAL STEROIDS AND OBSERVATION. THE AAO DOES NOT RECOMMEND PERFORMING A FLAP LIFT AND RINSE AT MILD STAGES. THE PHYSICIAN DID NOT FOLLOW TH RECOMMENDED TREATMENT PROTOCOL. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE BILATERAL CORNEAL FLAPS FOR LASIK SURGERY (EXACT DATE(S) NOT PROVIDED). POST-OPERATIVELY, PATIENT PRESENTED WITH STAGE 2 DIFFUSE LAMELLAR KERATITIS (DLK). A FLAP LIFT AND RINSE WAS PERFORMED ON BOTH (OU) EYES. PATIENT INFORMATION WAS REQUESTED FROM THE USER FACILITY, HOWEVER, NO PATIENT INFORMATION WAS PROVIDED. THE SURGEON CONFIRMED THAT THE PATIENT RESPONDED TO TREATMENT AND THE DLK HAS RESOLVED. THERE WAS NO LOSS OF VISUAL ACUITY (VA). 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 HNO AMO MANUFACTURING USA, LLC. 20003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention