Description of Event or Problem · 1
IN (B)(6) 2000, I HAD LASIK FOR POOR VISION. I EXPERIENCED PERMANENT BILATERAL HALOS, UNILATERAL "CLOUDY VISION" OF MY RIGHT EYE, DECREASED NIGHT VISION, AND EXTREME PHOTOSENSITIVITY, AS WELL AS FREQUENT AND SIGNIFICANT EYE PAIN AND BLURRY VISION. IN 2006, I HAD LASIK AGAIN FOR AN ENHANCEMENT. UNFORTUNATELY, MY SYMPTOMS DID NOT IMPROVE, AND IN FACT, THE PAIN WORSENED. SOME MORNINGS THE PAIN IS SO INTENSE THAT EVEN DIM LIGHT HURTS MY EYES. THEY TEAR SIGNIFICANTLY WHEN EXPOSED TO ROOM LIGHT, AND EVEN MORE WITH SUNLIGHT. IT IS DIFFICULT FOR ME TO WORK UNDER THESE CONDITIONS, SO I HAVE FOUND WAYS TO IMPROVE MY SYMPTOMS INCLUDING TAPING MY EYES SHUT AT NIGHT (SUGGESTED BY MY OPHTHALMOLOGIST) OR SLEEPING WITH A DAMP CLOTH ON TOP OF MY EYES TO PREVENT THEM FROM OPENING AT NIGHT AND DRYING OUT. I HAVE USED RESTASIS EYE DROPS AND AUTOLOGOUS SERUM EYE DROPS, WITHOUT SIGNIFICANT IMPROVEMENT. I STILL SEE HALOS BILATERALLY AND CLOUDY VISION, SIMILAR TO A DIRTY CONTACT LENS, IN MY RIGHT EYE. I LESS FREQUENTLY EXPERIENCE BLURRY VISION THESE DAYS. THE SIDE EFFECTS AS STATED ABOVE HAVE DECREASED MY QUALITY OF LIFE. WHEN I WAS IN UNDERGRAD AND IN MEDICAL SCHOOL, I HAD DIFFICULTY READING THE SCREEN IN A DIMLY LIT ROOM BECAUSE OF THE HALOS AND THE CLOUDINESS IN MY RIGHT EYE. I AM A CARDIOTHORACIC ANESTHESIOLOGIST AND AS SUCH, I EVALUATED AND TREATED PATIENTS WITH CHRONIC PAIN DURING MY RESIDENCY TRAINING. I BELIEVE I AM SUFFERING FROM A POSTOPERATIVE PAIN SYNDROME WHICH WAS NOT EMPHASIZED AS A RISK PRIOR TO CONSENTING FOR EITHER OF MY LASIK PROCEDURES. I PRESENTED PRIOR TO MY SECOND PROCEDURE WITH THESE SYMPTOMS. OF COURSE I WAS NOT OBTAINING TRULY INFORMED CONSENT. I'M CONCERNED THAT OTHER PATIENTS WILL SUFFER THE SAME SIDE EFFECTS DESPITE ADVANCES IN TECHNOLOGY. THANK YOU FOR YOUR TIME. DECREASED QUALITY OF LIFE. FDA SAFETY REPORT ID # (B)(4).