BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS3

    MDR report key: 3130667 · Received May 24, 2013

    Report

    Report Number
    3006695864-2013-00182
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AMO'S FIELD SERVICE ENGINEER WAS DISPATCHED FOR PREVENTATIVE MAINTENANCE. FSE COMPLETED THE PREVENTIVE MAINTENANCE. NO ADDITIONAL PROBLEMS OR OBSERVATIONS WERE MADE. SYSTEM MEETS ALL AMO SPECIFICATIONS. CUSTOMER REPORTED THAT THE CASE OF DLK HAD RESOLVED. THE SURGEON WAS BLAMING THE LASER ENERGY, SO THE CUSTOMER HAD AMO'S CLINICAL DEVELOPMENT MANAGER (CDM) IN FOR THEIR LAST CASE DAY. THEY HAD 2 MORE CASES OF DLK THAT NEEDED TO BE LIFTED BUT ONE WAS ON A PATIENT THAT THEY DID NOT USE THE INTRALASE ON SO THAT RULED OUT THE LASER. CUSTOMER INDICATED THAT NO CAUSE HAS BEEN IDENTIFIED. CUSTOMER WAS WONDERING IF IT WAS DUE TO SPONGE FIBERS, AS THE SURGEON RESTS A SPONGE OVER THE HINGE DURING ABLATION. SURGEON WILL CHANGE THAT NEXT TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 4 DIFFUSE LAMELLAR KERATITIS (DLK) CASES. ON (B)(6) 2013, PATIENT UNDERWENT UNEVENTFUL ILASIK ON BOTH EYES. CUSTOMER NOTED DLK ON BOTH EYES AT THE 1 DAY POST OP. SURGEON CHANGED STEROID FROM PRED FORTE FOUR TIMES DAILY (QID) TO DUREZOL QID. ON (B)(6) 2013, SURGEON ELECTED TO LIFT AND IRRIGATE LEFT FLAP. ON (B)(6) 2013, VISUAL ACUITY SANS CORRECTION WAS 20/20 RIGHT EYE AND 20/20 LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232792 INTRALASE FS3 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20004D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R