BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2223099 · Received August 15, 2011

    Report

    Report Number
    3006695864-2011-00075
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 19, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EPITHELIAL INGROWTH. EVAL: FIELD SERVICE SPECIALIST (FSS) CHECKED SYSTEM AFTER THE REPORTED EVENT ON (B)(4) 2011 AND PREVENTIVE MAINTENANCE WAS PERFORMED ON LASER. SYSTEM MEETS AMO SPECIFICATIONS.

    Description of Event or Problem · 1

    PRIMARY PROCEDURE ILASIK OU (B)(6) 2011. ON (B)(6) 2011, PT RETURNED FOR POST OP WITH VISUALLY SIGNIFICANT STRIAE AND MILD INGROWTH OD. REFLOATED / DEBRIDED / STRETCHED. F/U 24 HOURS. LAST SEEN (B)(6) 2011 SENT FOR F/U. RXM +1.25 -0.75 X 010 20/20, -.25 -1.00 X170 20/20. RE-CHECK 1 MONTH OR PRN PROBLEMS. CAN SCHEDULE ENHANCEMENT IF THE PT DESIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS2 LASER HNO AMO MANUFACTURING USA, LLC. 20003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention