BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUGLIDE MICROKERATOME DISPOSABLE BLADE

    MDR report key: 2560490 · Received May 18, 2010

    Report

    Report Number
    1920664-2010-00137
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    March 19, 2010
    Report Date
    April 21, 2010
    Manufacturer
    BAUSCH & LOMB
    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

    Description of Event or Problem · 1

    ON (B)(6) 2010, 1 DAY P/O LASIK OU. PT STATES OD IS A BIT FUZZIER THAN OS. PT NOTICES EYES ACHE AT TIMES VSC 20/50, 20/40. ON (B)(6) 2010, 2 DAYS P/O LASIK OU VA A LITTLE HAZY AND BETTER YESTERDAY. VSC 20/40, 20/30. ON (B)(6) 2010 POSSIBLE DLK. CONSULT WITH DR. INCREASE PF TO QHR OU WHILE AWAKE, SEE DR. TOMORROW A.M. ON (B)(6) 2010, STAGE 2 DLK, DISCUSSED WASH OUT TODAY, FOLLOW UP WITH DR. (B)(6). ON (B)(6) 2010, OS NOTE FLAP LIFT IRRIGATE FOR DLK PREP AND DRAPE, PROCAINE AND TETRACAINE. OS FIRST LIFT FLAP WITH SINSKEY, IRRIGATE BED AND BACK OF FLAP, SPONGE DRY AND WET PF 1% PLACED ON BED. EPI PUSHED BACK WITH TOOKE FLAP REPLACED, IRRIGATE, BCL. SAME PROCEDURE FOR OD. SLIT LAMP EXAM GOOD OU. DISCHARGE TO HOME (B)(6) 2010. ON (B)(6) 2010, PER AFFILIATE PT HAS RETURNED TO BCVA 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUGLIDE MICROKERATOME DISPOSABLE BLADE REFRACTIVE PRODUCTS HNO BAUSCH & LOMB NA 1142317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other