BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 2153237 · Received June 30, 2011

    Report

    Report Number
    MW5021233
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LASIK SURGERY IN 1997 AND 1998 FROM (B)(6) EYE CENTER IN (B)(6). I WAS VERY NEAR SIGHTED (B)(6). I NEEDED TWO ENHANCEMENTS FOR A TOTAL OF THREE SURGERIES. I HAVE EXPERIENCED DRY EYES AND GRADUAL NEAR SIGHTEDNESS. MY OPTOMETRIST HAS DIAGNOSED ME WITH ECTASIA AS A RESULT OF MY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASIK LZS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR