BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2492863 · Received March 11, 2012

    Report

    Report Number
    MW5024603
    Event Type
    Injury
    Date Received
    March 11, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 11, 2012
    Manufacturer
    NA
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK IN MY RIGHT EYE ON (B)(6) 2012. COMPLICATIONS BEGAN WITH A "BUNCHED UP" EPITHELIUM IN MY RIGHT EYE, WHICH CAUSED THE SURGEON TO DO A PRK PROCEDURE IN MY LEFT EYE. THE EPITHELIUM IN MY LEFT EYE. THE EPITHELIUM IN MY RIGHT EYE NEVER HEALED SMOOTHLY AND MY VISION WAS EXTREMELY BLURRY. THEREFORE, ABOUT TWO WEEKS AFTER SURGERY, MY RIGHT EYE REQUIRED A SECOND TREATMENT THAT INVOLVED THE SURGEON HAND-SCRAPING THE OUTER LAYER OF MY EYE OFF TO LET IT HEAL SMOOTHLY THE SECOND TIME. MUCH WORSE, HOWEVER, THE VITREOUS HUMOR IN MY RIGHT EYE BECAME DETACHED AND A LARGE "FLOATER" APPEARED IN MY RIGHT EYE. I SAW A RETINA SPECIALIST, WHO CONFIRMED THE VITREOUS HUMOR DETACHMENT IN MY RIGHT -LASIK- EYE, BUT FOUND NO SUCH DETACHMENT IN MY LEFT - PRK- EYE. I NOW FEEL AS IF I AM CONSTANTLY LOOKING THROUGH A SMUDGE OVER MY RIGHT EYE THAT I CAN'T WIPE AWAY. THE RETINA SPECIALIST SAID THAT I SHOULD CONSIDER MYSELF LUCKY NOT TO HAVE SUFFERED A DETACHED RETINA. LASIK SURGERY: (B)(6) 2012. FOLLOW-UP REMOVAL OF EPITHELIUM: (B)(6) 2012. VITREOUS DETACHMENT NOTICED: (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other