BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANSATOME

    MDR report key: 2554677 · Received June 4, 2010

    Report

    Report Number
    1920664-2010-00155
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 14, 2010
    Manufacturer
    TECHNOLAS PERFECT VISION
    Product Code
    HNO
    PMA / PMN Number
    K913697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO - MICROKERATOME. ADD'L INFO- BAUSCH & LOMB, (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2010, PRE OP VSC 20/40 OU. (B)(4). PACH 492/595. MR PLANO -1.25X100 -0.25-1.75X84 20/20 OU. CR PLANO-1.25X100 -0.25-1.75X084. DOS 5/6/10 LASIK OU. ON (B)(6) 2010, ONE DAY PO LASIK OU RIGHT EYE BLURRY. WOKE UP AFTER NOON YESTERDAY AND EYE WAS IRRITATED AND BURNING. VSC 20/40 20/30. DISPLACED FLAP, FLAP STRIAE - FLAP LIFT AND STRETCH. ON (B)(6) 2010, THREE DAYS POST FLAP LIFT OD, VASC 20/20 OD, 20/20-1 OS RXM -.25 SPHERE 20/20 OD, +.25 SPH 20/20 OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANSATOME ALK UNIT HNO TECHNOLAS PERFECT VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other