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Description of Event or Problem

THE FIRM, SYSTEMS OF SIGHT, INC. IS DEALING IN EYE GLASSES THAT ARE ADVERTISED TO IMPROVE THE VISION OF PEOPLE WITH MACULAR DEGENERATION, OPTIC NERVE DAMAGE OR SIMILAR LOW VISION PROBLEMS. THERE IS NO 510K FOR THIS DEVICE. MANUFACTURER CLAIMS THAT THE GLASSES OFFER IMPROVED SIGHT FOR PEOPLE WITH LOW VISION PROBLEMS SUCH AS MACULAR DEGENERATION, OPTIC NERVE DAMAGE OR THE LIKE. THE IMPROVED GLASSES COMPRISE A LENS ASSEMBLY HAVING A MAGNIFYING LENS FOR CONVERGING RECEIVED LIGHT AND A REDUCING LENS FOR DIVERGING RECEIVED LIGHT AND A FRAME FOR SUPPORTING THE LENS ASSEMBLY AT A PREDETERMINED DISTANCE FROM AN EYE OF A USER AND FOR SUPPORTING THE LENS IN A PREDETERMINED ORIENTATION WITH RESPECT TO EACH OTHER WITH THE LENSES DEFINING A SPACE THERE BETWEEN ALONG THE OPTICAL AXES OF THE LENS. FROM SPEAKING TO ONE COMPLAINANT THE STATE BELIEVES THESE CLAIMS TO BE FALSE AND IS SEARCHING FOR ADD'L CONSUMERS OF THIS PRODUCT.