BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK INTRALASE

    MDR report key: 1983643 · Received February 4, 2011

    Report

    Report Number
    MW5019324
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    July 10, 2009
    Report Date
    February 4, 2011
    Manufacturer
    *
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHRONIC DRY EYES AND HALOS AS A RESULT OF LASIK EYE SURGERY. I NOW HAVE DIFFICULTY AT WORK SEEING MY COMPUTER MONITOR. I TAKE 3X THE DAILY RECOMMENDED AMOUNT OF FISH OIL PILLS TWICE A DAY, I USE EYE DROPS EVERY 2 HRS -OPTIVE REFRESH PRESERVATIVE FREE. THESE COST ABOUT (B)(6) PER MONTH. I HAVE BLURRED VISION DUE TO THE DRY EYES AND ITCHY ANNOYING FEELING CONSTANTLY. AT NIGHT, I SEE SOME HALOS ALTHOUGH NOT BAD ENOUGH TO KEEP ME FROM DRIVING. THIS SURGERY WAS PERFORMED BY (B)(6) VISION CARE CENTER IN (B)(6). (B)(6), EVERY TYPE OF EYE DROP AVAILABLE OVER THE COUNTER. REFRESH OPTIVE 6X DAILY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK INTRALASE UNK LZS *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention