BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3191428 · Received June 26, 2013

    Report

    Report Number
    3006695864-2013-00234
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2013 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(4) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE EVENT) WILL MAKE THE EVALUATION DIFFICULT. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE. AMO'S CLINICAL DEVELOPMENT MANAGER HAD A DISCUSSION WITH THE CUSTOMER AND IT WAS DISCOVERED THE CULPRIT WAS THEIR AUTOCLAVE WHICH HAS BEEN SERVICED. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THREE PATIENTS WITH DIFFUSE LAMELLAR KERATITIS (DLK) AT DAY ONE POST OP. PATIENT HAD STAGE 2+ DLK. ALL HAVE RECOVERED WITH NO SURGICAL INTERVENTION. THEY ALL WERE TREATED WITH STEROID EYE DROPS AND ORAL STEROIDS. NO PATIENT INJURY AND NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). ANOTHER SURGEON HAS NOTICED SOME DLK CASES. SURGEON DOES NOT SEE IT ON ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291504 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other