FDA Adverse Event Injury Summary report: N

LASER

MDR report key: 1033972 · Received April 24, 2008

Report

Report Number
MW5006398
Event Type
Injury
Date Received
April 24, 2008
Date of Event
February 10, 2007
Report Date
February 24, 2008
Product Code
LZS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
DE, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DURING THE EARLY 2007, I UNDERWENT LASIK SURGERY. I WASN'T AS COMFORTABLE AS I EXPECTED AFTER THE FIRST COUPLE OF DAYS, BUT I EXPECTED THINGS TO PICK UP. I THOUGHT MY FEELINGS WERE USUAL FEELINGS AFTER HAVING SURGERY. BY THE BEGINNING OF THE 2ND WEEK I WOKE UP AND PANICKED, BECAUSE I WAS EXPERIENCING EXTREME PAIN IN MY EYES AND ANY LIGHT INTENSIFIED THE PAIN. I CONTACTED THE FACILITY WHERE THE SURGERY TOOK PLACE AND THEY ASKED ME TO COME IN. MY HUSBAND HAD TO DRIVE ME WHILE I WORE DARK PATCHES PURCHASED AT THE PHARMACY, DARK SUNGLASSES AND COWERED IN THE CORNER OF THE CAR, BECAUSE OF THE INTENSE PAIN CAUSED BY ANY LIGHT GETTING THROUGH. I HAD TO BE EVALUATED IN A DARK ROOM, BECAUSE I WAS UNABLE TO OPEN MY EYES IF THE LIGHT WAS ON. I WAS DIAGNOSED WITH IRITIS BY THE SURGEON AND PLACED BACK ON STEROID DROPS. THE PROBLEM SEEMED TO GET BETTER FOR ANOTHER WEEK OR SO AND THEN RETURNED REPEATEDLY. AFTER MANY TRIPS BACK TO THE FACILITY, THE SUREGON EXPRESSED THAT, I HAD TO HAVE HAD SOME UNDERLYING MEDICAL CONDITION PRIOR TO THE SURGERY THAT I WAS NOT AWARE OF. ONE NIGHT MY HUSBAND HAD TO TAKE ME TO EYE EMERGENCY ROOM BECAUSE MY EYES WERE SO BAD. EYE EMERGENCY ROOM WHO RESPECTED AND APPARENTLY HAD RECEIVED TRAINING FROM MY SURGEON AGREED WITH HIS DIAGNOSIS, AND AGAIN PUT ME BACK ON THE STEROID DROPS. THE SURGEON EXPLAINED THAT THEY COULD NOT DO ANYTHING MORE FOR ME AND REFERRED ME TO MY OPHTHALMOLOGIST FOR BLOOD WORK AND A CHEST X-RAY WHICH ALL CAME BACK FINE. NOW A LITTLE OVER YEAR LATER, MY VISION HAS STARTED TO REVERT BACK TO ITS ORIGINAL STATE, I EXPERIENCE DAILY BOUTS OF PAIN SHOOTING BEHIND MY EYES, OCCASIONAL BLURRED VISION - I HAVE TO LOOK AWAY AND REFOCUS - AND NO ONE SEEMS TO BE ABLE TO TELL ME WHY.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other