BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2 LASER

    MDR report key: 2824014 · Received November 23, 2010

    Report

    Report Number
    3006695864-2010-00128
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 25, 2010
    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). EVALUATION: EVALUATION OF EQUIPMENT IS IN PROGRESS. INFORMATION REGARDING THE RESULTS AND CONCLUSION OF THE EQUIPMENT EVALUATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PRE-OP 09/13/2010: VSC CF-OU VCC 20/30, OD 20/40, OS K'S 43.50/44.75 X 0.8843.25/44.75 X 075 PACH, 585 OD, 576 OS, MR - 5.75 - 1.00 X 170 -5.00 - 1.50 X 167 20/20 OU, CR 5.62 - 1.00 X 170 - 4.75 - 1.50 X 167 20/20 OU. (B)(6) 2010: 1 DAY POST OP. OU 20/25 OD 20/20 OS (LASIK) SUB CONJ HEM OD EPI IRREGULAR AT EDGE GREAT POSITION NO STRIAE FLAP SLIP OD. OP NOTE - SLIPPED FLAP OD. PREP AND GLOVE, DAPE, LIFT FLAP, REMOVE EPI FROM BED AND BACK OF FLAP. REPLACE AND STRETCH, BCL ZYMAXID, PRED FORTE. ONE DAY POST FLAP LEFT LIFT AND STRETCH VASC 20/20 OD.

    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 36 YR Other