BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 2930697 · Received January 28, 2013

    Report

    Report Number
    3006695864-2013-00019
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 26, 2012
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). STRIAE. CONCLUSION - THE EQUIPMENT WAS NOT EVALUATED AFTER THE TREATMENT DATE WHICH OCCURRED ON (B)(6) 2012. CUSTOMER INDICATED THAT THE INITIAL SURGERY WAS UNEVENTFUL. THE CLINIC REPORTED THIS EVENT ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT UNEVENTFUL ILASIK (B)(6) 2012. PRESENTED FOR 2 MONTH POSTOP (B)(6) 2012 COMPLAINING OF CHANGE IN VISION ON LEFT EYE (OS). SLIT LAMP EVALUATION (SLE) NOTED STRIAE OS. ELECTED TO LIFT AND STRETCH FLAP OS. VISUAL ACUITY SANS CORRECTED (VASC) PRIOR TO LIFT OS WAS 20/20 BUT PATIENT COMPLAINED OF SHADOWS TEMPORARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36440 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R