BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3191717 · Received June 26, 2013

    Report

    Report Number
    3006695864-2013-00241
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 OR CLINICAL SUPPORT. AMO'S CLINICAL DEVELOPMENT MANAGER CONTACTED THE SITE TO OBTAIN PATIENT INFORMATION. CUSTOMER STATED ALL PATIENTS WERE DOING WELL, WITH NO RESIDUAL DLK, NOR LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). CUSTOMER BELIEVED THE DLK WAS DUE TO SOMETHING ENVIRONMENTAL. THEY WERE HAVING THE AUTOCLAVE SWITCHED OUT TO RULE THAT OUT. ONE THING THAT CAUGHT THE CDM'S ATTENTION WAS A DROP THEY WERE USING. CUSTOMER HAD SWITCHED OVER TO DUREZOL AROUND THE TIME THE DLK BEGAN. CDM SPOKE WITH THE CUSTOMER ON (B)(4) 2013 AND THEY HAD DISCONTINUED THE DUREZOL ON THE PREVIOUS SURGERY DAY ((B)(6) 2013) AND THE POST OPS ON THE FOLLOWING DAY DID NOT HAVE ANY DLK. IT APPEARS TO HAVE POSSIBLY BEEN ASSOCIATED WITH THE DUREZOL, AS THEY HAVE NOT YET HAD A CHANCE TO CHANGE OUT THE AUTOCLAVE. THEY ARE DISCONTINUING THE DUREZOL AT THIS TIME. NO OTHER ISSUES TO REPORT. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2 CASES WITH DIFFUSE LAMELLAR KERATITIS (DLK). PATIENT WITH TRACE DLK ON BOTH EYES. PATIENT PRESCRIBED WITH DUREZOL. UNCORRECTED VISUAL ACUITY WAS 20/20 ON THE RIGHT EYE AND 20/20 ON THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290183 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other