IN LIGHT WELLNESS SYSTEMS LED LIGHT THERAPY DEVICE

Additional Manufacturer Narrative

IN LIGHT WELLNESS SYSTEMS HAS CONTACTED THE CLINIC AND PATIENT FOR ADDITIONAL INFORMATION. THE CLINIC HAS NOT YET RETURNED THE DEVICE FOR INVESTIGATION. AT THIS TIME, THE PATIENT IS UNWILLING TO RESPOND TO ANY QUESTIONS. THE DHR WAS REVIEWED AND SHOWS THAT THE DEVICE WAS MANUFACTURED TO THE CURRENT STANDARDS AND DID NOT PRESENT ANY NON-CONFORMANCES THROUGH BUILDING AND TESTING.

Description of Event or Problem

PATIENT REPORTED THAT EXPOSURE TO "IN LIGHT WELLNESS SYSTEM" AGGRAVATED A PRE-EXISTING HERPESVIRAL KERATITIS EYE INFECTION THAT WAS VIRTUALLY IN REMISSION. INFECTION WAS RE-IGNITED, WITH SIGNIFICANT INFLAMMATION AND DAMAGE TO HIS CORNEA, DESPITE USE OF ZIRGEN AT THE TIME. PATIENT ALLEGED THERE WERE NO WARNINGS OR QUESTIONS REGARDING EYE INFECTIONS. LIGHT WAS DIRECTED TO HIS EYES.