BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2961510 · Received February 14, 2013

    Report

    Report Number
    3006695864-2013-00041
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO A 1 DAY POST LASIK PROCEDURE WITH A DISPLACED FLAP NASALLY IN THE RIGHT EYE (OD) WITH MICROSTRIAE. THE FLAP WAS RESET IN OFFICE ON (B)(6) 2013. NO COMPLICATIONS WITH THIS PROCEDURE. FLAP WAS IN GOOD POSITION. BCL PLACED OD, NO COMPLICATIONS WITH BANDAGE CONTACT LENS (BCL) EITHER. PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) ON (B)(6) 2013 WAS 20/40 OD AND 20/30 LEFT EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65424 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R