BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2955938 · Received February 11, 2013

    Report

    Report Number
    3006695864-2013-00036
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(4) 2013. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER DISCOVERED INFLAMMATION ON THE LEFT EYE (OS). PATIENT FELT THAT AFFECTED EYE (OS) IS BLURRIER THAN NOT AFFECTED RIGHT EYE (OD). UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2013, WAS 20/15 OD AND 20/20 OS. SECRETIONS FROM MEIBOMIAN GLANDS IN FLAP INTERFACE. A FLAP LIFT AND RINSE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58004 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R