BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3173506 · Received June 17, 2013

    Report

    Report Number
    3006695864-2013-00213
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 19, 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

    (B)(4). EVALUATION CODES: 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 REPORTED AN UNEVENTFUL TREATMENT AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL ILASIK (B)(6) 2013. PATIENT PRESENTED AT 1 DAY POST OP AND AFFILIATE NOTED SIGNIFICANT DEBRIS UNDER THE FLAPS ON BOTH EYES. PATIENT REFERRED BACK TO THE CENTER. SLIT LAMP EXAM NOTED SIGNIFICANT AMOUNT OF MEIBOMIAN DEBRIS UNDER THE FLAPS, FLAPS LIFTED AND IRRIGATED ON BOTH EYES. PATIENT SEEN ON (B)(6) 2013, PATIENT'S INTERFACE CLEAR, VISUAL ACUITY SANS CORRECTION (VASC) 20/25 ON THE RIGHT EYE AND 20/40 ON THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272919 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R