BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3232496 · Received July 18, 2013

    Report

    Report Number
    3006695864-2013-00275
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    March 7, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: 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. THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. PLACEHOLDER.

    Description of Event or Problem · 1

    AT 5 MONTH POST OP, PATIENT WITH GOOD VISUAL ACUITIES ON BOTH EYES. PATIENT PRESENTED WITH STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK) AND DIFFUSE HAZE ON THE RIGHT EYE. PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY. ADDITIONAL FOLLOW UP WAS OBTAINED. PATIENT¿S SYMPTOMS HAD NOT RESOLVED, BUT VISION IS STABLE 20/20. PATIENT WAS RELEASED FROM CARE. THERE WAS NO LIFT AND RINSE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333348 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other