BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2961918 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00044
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 18, 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): CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2012. THE INITIAL PROCEDURE WAS UNEVENTFUL. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT ILASIK ON (B)(6) 2012. PATIENT PRESENTED 4 DAYS POST OP COMPLAINING OF CHANGE OF VISION ON BOTH EYES (OU). SLIT LAMP EVALUATION (SLE) NOTED STRIAE OU. PATIENT BROUGHT BACK TO LASER SUITE AND FLAPS LIFTED AND STRETCHED OU. POST OP ON (B)(6) 2013, VISION ON RIGHT EYE (OD) 20/30 AND LEFT EYE (OS) 20/40. LAST POST OP ON (B)(6) 2013. VISUAL ACUITY SANS CORRECTION (VASC) 20/50 OD AND 20/40 OS. BEST CORRECTED VISUAL ACUITY (BCVA) +1.50 20/25 OD AND + 0.75 20/20 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66140 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R