BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 3252873 · Received July 29, 2013

    Report

    Report Number
    3006695864-2013-00302
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT SINCE THERE WAS NO INDICATION THAT A MALFUNCTION CAUSED THE REPORTED ISSUE. THE CLINIC IS REPORTING THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. AMO''S FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2013 FOR A PREVENTIVE MAINTENANCE AND DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE EVENT.NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    FLAP STRIAE NOTED ON ONE DAY POST OP. PATIENT WAS TREATED WITH PRED FORTE. FLAP LIFT AND REPOSITION WAS PERFORMED SAME DAY. NO LOSS OF BEST CORRECTED VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353752 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other| R