BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3173857 · Received June 17, 2013

    Report

    Report Number
    3006695864-2013-00217
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 19, 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 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. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT HAD AN UNEVENTFUL ILASIK ON (B)(6) 2013. PATIENT PRESENTED ON (B)(6) 2013, WITH A PATCH OF EPITHELIAL INGROWTH ON THE LEFT EYE. SURGEON FELT IT WAS BEST TO REMOVE. FLAP LIFTED AND EPITHELIAL INGROWTH REMOVED ON THE LEFT EYE. PATIENT SEEN ON (B)(6) 2013, VISUAL ACUITY SANS CORRECTION (VASC) WAS 20/20 ON THE RIGHT EYE AND 20/20-2 ON THE LEFT EYE. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274368 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R