Description of Event or Problem · 0
ON (B)(6) 2025 I BEGAN A 9 TREATMENT SESSION OF LIGHT THERAPY USING THE VALEDA LIGHT SYSTEM AS RECOMMENDED BY MY EYE DOCTOR OF SIX YEARS. PRIOR TO THIS TREATMENT, MY EYESIGHT WAS VERY GOOD AND I WAS BEING MONITORED FOR MILD TO MODERATE DRY, AGE-RELATED MACULAR DEGENERATION (AMD). MY DOCTOR RECOMMENDED THIS LIGHT THERAPY TO HELP REDUCE THE RISK OF FUTURE EYE DAMAGE. WITHIN THE FIRST WEEK OR TWO OF TREATMENT, I BEGAN TO NOTICE SOME CHANGES IN MY VISION BUT HAD ATTRIBUTED IT TO MY READING GLASSES. BY THE THIRD WEEK OF TREATMENT, I NOTICE SIGNIFICANT WAVINESS IN MY WINDOW BLINDS, MY TV SCREEN AND FINALLY THE EYE TEST GRID I POSSESSED. THE FOLLOWING DAY, (B)(6) 2025, I SAW MY EYE DOCTOR WHO INFORMED MY THAT MY DRY AMD HAD CONVERTED TO WET AMD AND THAT I WOULD NEED EYE INJECTIONS EVERY MONTH GOING FORWARD IN MY LIFE. I WAS NEVER INFORMED THAT THIS COULD BE A POSSIBLE SIDE EFFECT, AND WAS ALSO TOLD THAT THE FDA RECENTLY DETERMINED THIS TREATMENT TO BE SAFE. THE ONLY SIDE EFFECT DISCUSSED WAS A TEMPORARY PHOTOSTRESS AFTERIMAGE AFTER TREATMENT. I SUBSEQUENTLY READ A RESEARCH REPORT PERTAINING TO VALEDA LIGHT SYSTEM IN WHICH IT WAS FOUND THAT 5.4 PERCENT OF A TREATED GROUP EXPERIENCED CONVERSION TO WET AMD, COMPARED TO 1.8 FOR A SHAM GROUP. NONE OF THIS WAS DISCUSSED WITH ME PRIOR TO TREATMENT. I NOW HAVE PERMANENT DAMAGE TO MY EYE DUE TO THIS TREATMENT AND ENCOURAGE THE FDA TO REQUIRE FURTHER TESTING SO THAT OTHERS DO NOT EXPERIENCE THE SAME OUTCOME.