BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2991915 · Received March 6, 2013

    Report

    Report Number
    3006695864-2013-00072
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION - THE CLINIC IS REPORTING 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.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED ON (B)(6) 2013 POST OP WITH DEBRIS UNDER THE FLAP IN THE LEFT EYE (OS). THE FLAP WAS LIFTED AND RINSED ON (B)(6) 2013. THE PATIENT DID NOT EXPERIENCE VISION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96205 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R