BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS1

    MDR report key: 3022055 · Received March 26, 2013

    Report

    Report Number
    3006695864-2013-00102
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 25, 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). EVALUATION CONCLUSION: - CUSTOMER IS ONLY REPORTING THIS EVENT AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL ILASIK ON (B)(6) 2012. PATIENT PRESENTED AT THE POST-OP WITH EPITHELIAL INGROWTH ON THE LEFT EYE (OS). VISUAL ACUITY SANS CORRECTION (VASC) WAS 20/20 RIGHT EYE (OD) AND 20/20-1 OS. PATIENT WAS BROUGHT TO THE CENTER, FLAP LIFTED AND EPI INGROWTH WAS REMOVED. PATIENT SEEN ON (B)(6) 2013, VASC WAS 20/40 OS. BANDAGE CONTACT LENS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124508 INTRALASE FS1 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20002

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R