BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2176718 · Received July 14, 2011

    Report

    Report Number
    3006695864-2011-00065
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOUDY AND IRRITATION. AT THE TIME OF THIS REPORT EQUIPMENT EVAL HAS NOT BEEN COMPLETED. WHEN THE EQUIPMENT EVAL IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PRE OP VSC 20/400 OU. VCC 20/25 20/30. PACH 523/524. W OD -4.74-0.25X112 OS -4.75-0.74X112 K OD, 44.37/43.87X104 OS 44.62/44.25X051. MR OD -4.75-1.00X083 OS -4.75-0.75X085 20/25 20/20. ON (B)(6) 2011, 1 DAY POST OP LASIK OU. RIGHT EYE CLOUDY AND IRRITATED. VSC 20/400 20/25. ON (B)(6) 2011, FLAP LIFTED AND REPOSITIONED. ON (B)(6) 2011, PT DOING BETTER, NO PAIN - VASC 20/30 OD, 20/20 OS. RE-CHECK 1 WEEK.

    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 48 YR Required Intervention