BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3160378 · Received June 10, 2013

    Report

    Report Number
    3006695864-2013-00200
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    March 16, 2013
    Report Date
    May 15, 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

    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 INDICATED THAT THE INITIAL PROCEDURE WAS UNEVENTFUL AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT UNDERWENT UNCOMPLICATED LASIK INTRALASE ON BOTH EYES. ON HIS 1 DAY POST OP, CUSTOMER NOTED LEFT EYE FELT A LITTLE SORE AND BLURRY. PATIENT DENIED RUBBING THE EYE, BUT WIFE STATED THAT EYE WAS SLIGHTLY OPEN WHEN SLEEPING AND HEATER IS ON LEFT SIDE OF FACE. ON EXAM, IT WAS NOTED A DISLODGED/SLIPPED FLAP OF APPROXIMATELY 2 MM SUPERIORLY. PATIENT WAS TAKEN TO THE SURGERY SUITE AND FLAP WAS LIFTED RINSED, STRETCHED AND REPOSITIONED. PATIENT INSTRUCTED TO GO HOME AND TAKE 4 HOUR NAP AND RESTART DROPS AS IF IT WERE DAY 1. PATIENT EXAMINED NEXT DAY ON (B)(6) 2013, WHERE FLAP WAS FOUND TO BE IN GOOD POSITION. VISION 20/50 ON THE LEFT EYE WITH A FEW SOFT STRIAE REMAINING. PATIENT WAS SEEN ON (B)(6) 2013, SLIT LAMP EXAM NOTED FLAPS IN GOOD POSITION AND VISUAL ACUITY SANS CORRECTION WAS 20/20 ON BOTH EYES. ADDITIONAL FOLLOW UP WAS OBTAINED. STRIAE WAS RESOLVED AT DAY OF INTERVENTION. PATIENT IS DOING WELL. NO SUTURES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259893 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R