BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2992932 · Received March 7, 2013

    Report

    Report Number
    3006695864-2013-00074
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CUSTOMER DID NOT FEEL THE INTRALASE IS THE CAUSE OF THE INFLAMMATION. AMO''S CLINICAL DEVELOPMENT MANAGER (CDM) RECOMMENDATIONS MADE TO THIS ACCOUNT: USE STERILE WATER (INSTEAD OF FILTERED WATER) FOR INSTRUMENT CLEANING, RINSING AND TO FILL STATIM STERILIZER. CLEAN INSTRUMENTS IN FRESH CLEANING WATER AND TWO RINSES (WITH STERILE WATER). CHANGE WATER BETWEEN PATIENTS. EMPTY WASTE BOTTLE AFTER EACH SURGERY DAY, RINSE IT AND REFILL WITH FRESH WATER BEFORE EACH USE. MAY WANT TO TRY SWITCHING TO LATEX FREE GLOVES FOR ALL PATIENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE DIFFUSE LAMELLAR KERATITIS (DLK) CASES THAT WERE OBSERVED ON (B)(6) 2013 AT ONE DAY POST-OP. PATIENT HAD TRACE DLK ON BOTH EYES (OU). PATIENT WAS TREATED WITH PREDFORTE. UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2013 WAS 20/15 RIGHT EYE (OD) AND 20/25 LEFT EYE (OS). ON (B)(6) 2013, UCVA WAS 20/15 BOTH EYES AND DLK WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98210 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other