FDA Adverse Event Injury Summary report: N

LASIK COMPUTER/MACHINE

MDR report key: 2973797 · Received February 14, 2013

Report

Report Number
MW5029017
Event Type
Injury
Date Received
February 14, 2013
Date of Event
January 1, 2000
Report Date
February 14, 2011
Manufacturer
UNK
Product Code
LZS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2000, I HAD LASIK EYE SURGERY IN BOTH EYES, PERFORMED BY DR (B)(6) IN (B)(6). I WAS TOLD I WAS A "PERFECT CANDIDATE" BECAUSE I HAD BAD VISION AND BAD ASTIGMATISM. WHEN IT WAS OVER, THEY SAID I HAD 20/20 VISION WITHOUT GLASSES, ALTHOUGH MY SIGHT WASN'T NEAR AS CLEAR AS WHEN I HAD WORN GLASSES. AT FIRST, I WAS THRILLED THAT I COULD GO TO THE BEACH AND GO OUT INTO THE WATER AND STILL BE ABLE TO SEE EVERYTHING, WITH NO GLASSES. THE PROBLEM STARTED VERY QUICKLY, HOWEVER. MY NIGHT VISION WAS DESTROYED IMMEDIATELY, AND IT BECAME EXTREMELY DIFFICULT TO DRIVE AT NIGHT. I HAD EXTREME DRY EYE SYNDROME, AND NOTHING RELIEVED IT, NOT EVEN PLUGS INSERTED INTO MY TEAR DUCTS. MY VISION FLUCTUATED ALL THE TIME. ONE DAY I COULD READ THE COMPUTER MONITOR OK, THE NEXT DAY I COULDN'T. IT BECAME A CONSTANT SOURCE OF STRESS. MY EYES WERE NOW ALSO EXTREMELY SENSITIVE TO SUNLIGHT. ONLY 6 YEARS AFTER THE SURGERY, I HAD TO START WEARING GLASSES AGAIN. UNLIKE THE PAST, HOWEVER, IT WAS VERY DIFFICULT FOR THE EYE DOCTORS TO FIND A PRESCRIPTION, BECAUSE OF THE CONSTANT VISION FLUCTUATION. AND I WAS HAVING TO CHANGE PRESCRIPTIONS FREQUENTLY, WHICH IS EXPENSIVE. MY EYES CONTINUE TO GET WORSE AND WORSE. THE ASTIGMATISM STARTED TO COME BACK, AND I HAVE A SCAR ON MY LEFT CORNEA. I HAVE TO GET A NEW EYEGLASS PRESCRIPTION ABOUT EVERY 3 MONTHS NOW, AND I USUALLY CANNOT SEE ANYTHING CLEARLY FOR LONG. I NEVER KNOW HOW MY EYESIGHT WILL BE FROM DAY TO DAY. MY EYES CONTINUOUSLY HURT AND BURN, AND I ALWAYS HAVE A BUNCH OF "JUNK" IN MY EYES. READING A BOOK OR THE COMPUTER MONITOR IS EXTREMELY HARD, AND I'M GETTING TO THE POINT WHERE MANY DAYS I CANNOT SEE WELL ENOUGH TO DRIVE DURING THE DAYTIME! I HAVE TO STICK TO ROADS THAT I KNOW VERY WELL, HAVE A LOT OF BLURRINESS, AND CANNOT READ SIGNS UNTIL I'M UP ON THEM. I SUSPECT THAT IT WON'T BE LONG UNTIL I HAVE TO GIVE UP DRIVING. OF COURSE I THOUGHT ABOUT SUING THE DOCTOR, BUT CONVENIENTLY FOR HIM, THE STATUTE OF LIMITATIONS ON MEDICAL MALPRACTICE IS ONLY 2 YEARS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
66306 LASIK COMPUTER/MACHINE LASIK MACHINE LZS UNK

Patients

Seq Age Sex Outcome Treatment
1 38 YR Congenital Anomaly| H| L| O| R| S