BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2993219 · Received March 7, 2013

    Report

    Report Number
    3006695864-2013-00077
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 6, 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 DUE TO THE FACT ABBOTT MEDICAL OPTICS (AMO) BECAME AWARE ON (B)(6) 2013. THE CONDITION OF THE SYSTEM (SINCE THE TIME OF THE INITIAL PROCEDURE) WILLMAKE THE EVALUATION IMPOSSIBLE. CUSTOMER INDICATED THAT THE PROCEDURE WAS UNEVENTFUL AND IS ONLY REPORTING THIS EVENT. CUSTOMER DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNCOMPLICATED CUSTOM INTRALASE ON THE RIGHT EYE (OD), ON (B)(6) 2012. AT THE PATIENT''S 1 WEEK FOLLOW-UP WITH HER AFFILIATE, PATIENT''S AFFILIATE NOTED A FEW STRIAE. WHEN CUSTOMER EXAMINED THE PATIENT ON (B)(6) 2012, PATIENT DID HAVE SOME HORIZONTAL STRIAE OVER THE PUPIL MARGIN. PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) OD WAS 20/30. REFRACTION OF PL - 1.00X 15, BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25+. PATIENT DENIED RUBBING EYE. THE PATIENT WAS BROUGHT BACK TO (B)(6) ON (B)(6) 2013 WHERE PATIENT'S OD WAS PREPPED, THEN TAKEN INTO THE SURGERY SUITE. FLAP WAS LIFTED, STRETCHED AND SMOOTHED BACK DOWN INTO PROPER POSITION. UPON SLIT LAMP EXAM IMMEDIATELY FOLLOWING THE PROCEDURE, THE FLAP APPEARED IN GOOD POSITION AND GUTTERS WERE FREE OF DEBRIS. THE PATIENT WAS INSTRUCTED TO TAKE ZYMAXID FOUR TIMES DAILY (QID) OD X 7 DAYS AND PREDNISOLONE DROPS QID X 7 DAYS. ON (B)(6) 2013, VISUAL ACUITY SANS CORRECTION (VASC) WAS 20/25 RXM PLANO=1.00X150 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96945 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R