UV ULTRA LIGHT

Description of Event or Problem

I WAS PUT IN THE (B)(6) STUDY IN (B)(6) 2013, DUE TO SEVERE FLUCTUATING VISION. I HAD RADIAL KERATOTOMY IN THE LATE 90'S. (B)(6) 2013, THE DR ADDED TCK SURGERY, THE DAY BEFORE CORNEAL COLLAGEN CROSS-LINKING. HE WELDED 48 SPOTS IN MY LEFT EYE. I LOST ALL FUNCTIONAL VISION RIGHT AFTER WITH SEVERE PAIN. THE CXL WAS THE FOLLOWING MORNING. IMMEDIATELY AFTER MY VISION WAS EVEN MORE DISTORTED. DOUBLE AND TRIPLE VISION, LOOKING THRU CRINKLED SARAN WRAP. SEVERE DRY EYE AND EXTREME PAIN. THE TCK WAS TO CLOSE THE CUTS MADE BY RK. WHEN I RETURNED HOME A WEEK LATER, MY LOCAL DOCTOR SAID MY EYE WAS LITERALLY SPLAYED OPEN. I CANNOT DRIVE, OR DO THE THINGS I USED TO. ONE YEAR LATER, THE DOCTOR, THAT DID THE FDA STUDY BLAMED THE FAILURE OF THE STUDY ON MY NONCOMPLIANCE WITH DRY EYE. AND HE COULD DO NOTHING ELSE. HE LITERALLY DUMPED ME AND MY STUDY. I HAVE NOT HEARD FROM HIM SINCE. AND MY EYE IN NOW USELESS. AND I HAVE NO WHERE TO TURN. I CAN'T FIND WHY HE DID THE TCK, AS MY EYE WAS FLUCTUATING SEVERELY, AND IT IS NOT A CANDIDATE FOR THAT PROCEDURE. I HAVE LOST MY QUALITY OF LIFE DUE TO PAIN AND VERY POOR VISION. WHAT RECORDS I DID FINALLY RECEIVE, WAS NOT ACTUAL OR FACTUAL. MY STUDY FAILED AND HE THREW IT OUT. MY LAST VISIT, THE GIRL DOING THE REFRACTIONS WAS NEW AND KEPT SAYING THE EQUIPMENT WAS NOT WORKING.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON (B)(6) 2016: I WROTE A REPORT IN REGARDS TO A FDA STUDY THAT INCLUDED CXL AND TCK. THIS PROCEDURE WAS DONE (B)(6) 2013. THE MDR REPORT KEY (B)(4), REPORT #3007851054-2015-00001, REPORT DATE 06/23/2015. IT WAS DONE BY DR. (B)(6)AT (B)(6). TCK WAS DONE WITH 48 SPOTS ON MY LEFT EYE, FOLLOWED BY CXL THE NEXT MORNING. MY STUDY # (B)(4). MY STUDY (SURGERY DOES NOT SHOW UP ON THE FDA AND THAT THERE WAS NO STUDY OF THIS KIND AT THE TIME.) THE TCK SURGERY DAMAGE WAS INSTANT, I LOST ALL QUALITY VISION AND HAD SEVERE PAIN. THE CXL SURGERY WAS DONE 24 HOURS LATER AND AS OF TODAY (B)(6) 2016 MY VISION HAS NOT IMPROVED. I DEAL WITH EXTREME HEADACHES CAUSED BY THE MONOVISION THE TCK CAUSED, AND THE CXL PROCEDURE DONE WITHIN 24 HOURS SPLAYED MY CORNEA OPEN. I CANNOT DRIVE, BIKE RIDE ETC. I HAVE NO QUALITY OF LIFE I SUFFER FROM SEVERE DEPRESSION AND SUICIDAL THOUGHTS DUE TO THIS. I AM CONFUSED AS TO THE FOLLOW UP REPORT BY THE FDA THAT MY SURGERY DID NOT EXIST. THAT THERE WAS NO STUDY OF THIS PROCEDURE. MY NAME IS (B)(6) AND LIVE IN (B)(6).