BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2974769 · Received February 22, 2013

    Report

    Report Number
    3006695864-2013-00058
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEIBOMIAN GLAND SECRETIONS HAD RESOLVED AND THE PATIENT HAD BCVA OF 20/20 IN BOTH EYES.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2013. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. THERE WAS NO INDICATION THAT THE MEIBOMIAN GLAND DYSFUNCTION SECRETIONS WERE CAUSED BY THE LASER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER REPORTED MEIBOMIAN GLAND DYSFUNCTION (MGD) SECRETIONS AT 6 O'CLOCK ON PATIENT''S RIGHT EYE (OD). PATIENT DID NOT EXPERIENCE LOSS OF BEST CORRECTED VISUAL ACUITY. PATIENT WAS PRESCRIBED PREDFORTE 1%. A FLAP LIFT AND RINSE WAS PERFORMED. ON (B)(6) 2013, UNCORRECTED VISUAL ACUITY (VA) WAS 20/COUNTING FINGERS (CF) RIGHT EYE (OD) AND 20/200 LEFT EYE (OS). ON (B)(6) 2013, BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 OD AND 20/20 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78630 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R