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While training in maxillofacial prosthetics at the University of Tennessee under the supervision of Dr. David Cagna, Matt Singer was regularly exposed to acrylic used to create both dentures, and artificial eyes. His adverse physical reaction to the resin was undeniable. He realized his reaction could not be unique, and over the course of two years, developed a silicone ocular prosthetics system with the absolute highest quality silicone available.
All the components of the Flexiglass silicone ocular prosthetic system have companion FDA Material Master Files. FDA Material Master Files have been around for a long time. The FDA can be quoted as saying “We only want to look at the data once.” thus, device manufacturers do not have to repeat expensive and time consuming biocompatibility testing, and can concentrate on device design and performance. Recent reports from the Journal of Epidemiology, National Cancer Institute, New England Journal of Medicine and British Institute of Health (Ref. 1, 2, 3, 4 below) confirm that properly formulated silicones are the most biocompatible materials available.
This patent pending process was developed with the Ocularist in mind. Making a silicone ocular prosthesis is very similar to producing one in acrylic. There are only a few differences including the painting and the polish process. The time it takes to make a silicone eye is comparable to that of an acrylic eye.