Description of Event or Problem · 0
TMS CAUSED EYE FLOATERS; I HAD CATARACT SURGERY ON MY LEFT EYE ON (B)(6) 2022. SURGERY WAS SUCCESSFUL. I BEGAN TMS THERAPY 2 WEEKS LATER, ON (B)(6) 2022. AFTER 3 SESSIONS ON CONSECUTIVE DAYS, I NOTICED A SHEER, GRAYISH "VEIL" OF FLOATERS IN MY LEFT EYE. TMS WAS DISCONTINUED. MY PSYCHIATRIST SAID HE WAS UNAWARE OF THE POSSIBILITY OF THIS SIDE EFFECT. MY OPHTHALMOLOGIST WAS UNFAMILIAR WITH TMS, BUT BECAUSE OF THE SURGERY, MY EYES HAD BEEN EXAMINED, MAPPED, AND EXAMINED SOME MORE OVER A PERIOD OF SEVERAL WEEKS PRIOR TO AND FOLLOWING THE CATARACT SURGERY. SHE NOTICED THE "VEIL" OF FLOATERS, WHICH SHE DESCRIBED AS A "HAZE" AND SAID SHE MIGHT BE ABLE TO REMOVE IT WITH A LASER AT SOME FUTURE DATE. I DEVELOPED A COUPLE OF DISTINCT FLOATERS IN MY RIGHT EYE 2.5 YEARS AGO, ABOUT 6 MONTHS AFTER A CYCLING ACCIDENT, BUT HAD NO HISTORY OF FLOATERS IN MY LEFT EYE UNTIL THE TMS. A SEARCH OF THE LITERATURE YIELDS VERY LITTLE ABOUT FLOATERS AND TMS. HOWEVER, IT WOULD BE VERY HARD TO PUT TOGETHER A RESEARCH STUDY OF PEOPLE WHO UNDERWENT CATARACT SURGERY IMMEDIATELY BEFORE TMS. I BELIEVE THAT TMS SHOULD ABSOLUTELY BE CONTRAINDICATED FOLLOWING CATARACT SURGERY, ESPECIALLY ON THE LEFT EYE, GIVEN THE PLACEMENT OF THE TMS DEVICE AND ITS PAINFULLY PERCUSSIVE NATURE. I WANT OTHER PATIENTS TO BE PROTECTED FROM HAVING THIS PROBLEM. THE VEIL OF FLOATERS WAS FIRST NOTICEABLE ON THE UPPER 1/3 OF MY FIELD OF VISION. NOW, 3 WEEKS AFTER CEASING TMS, THE VEIL COVERS THE ENTIRE FIELD OF VISION IN MY LEFT EYE. IT IS NOT ANYTHING APPROACHING BLINDNESS, BUT GIVEN THE FACT THAT I'VE JUST UNDERGONE SURGERY TO IMPROVE MY VISION, IT IS TERRIBLY DISAPPOINTING TO HAVE MY VISION NEGATIVELY IMPACTED BY THE TMS THERAPY WHICH WAS SUPPOSED TO IMPROVE MY LIFE. I HAVE JUST HAD CATARACT SURGERY ON MY RIGHT EYE, REQUIRING MULTIPLE FOLLOWUP APPOINTMENTS WITH THE OPHTHALMOLOGIST, SO SHE WILL BE ABLE TO MONITOR THE "HAZE" IN MY LEFT EYE. I PRAY THAT MY VISION WILL NOT BE FURTHER DAMAGED BECAUSE OF THE TMS. I AM A HEALTHY (B)(6) WOMAN. PRIOR TO THE CATARACT SURGERY, I REQUIRED OVER-THE-COUNTER READING GLASSES ONLY. THE CATARACT SURGERY WAS INTENDED TO IMPROVE MY DISTANCE VISION, WHICH WAS BEGINNING TO DETERIORATE. I AM A CYCLIST AND HAD BEGUN TO FIND THAT MY DISTANCE VISION WAS NOT AS SHARP AS NECESSARY TO BIKE SAFELY. I DO NOT OWN THE "PRODUCT" THAT WAS USED. THE TMS DEVICE IS USED AT MY PSYCHIATRIST'S OFFICE. IT WAS INTENDED TO TREAT PTSD AND MAJOR DEPRESSIVE DISORDER. FDA SAFETY REPORT ID # (B)(4).