BioEye is a medical device which includes:
- Practically unbreakable medical grade pmma material
- High fidelity processing and manufacturing polymerization
- Clinical investigation based fitting method, followed by ophthalmic specialists
- Multi layer 3D aesthetic parts manufacture (iris, veins, scleral tissue)
BioEyes are manufactured from EYEART Laboratories which is certified according to medical device ISO 13485 for the manufacture of ocular prostheses, epithesis and contact lenses and also registered medical device manufacturer at National Health Organisation.
Every BioEye has a unique serial number which is safely sealed under the transparent part of the prostheses. In this way device traceability is ensured, according to european legislation.
Material
Pmma is the material hard contact lenses are manufactured, used for decades, as well as parts of some intraocular lenses used today in cataract surgery. Biocompatibility with ocular tissue is tested for multiple years.
Ellaboration/Polymerization
The polymerization and material ellaboration follow the most stable protocols used, in the way of making BioEye absolutely biocompatible, stability in time, normal tissue function under the eyelids.
Selective Buckling Fitting (SBF) technique
The special fitting method is a result of long clinical research from the clinical team in EYEART Laboratories. The fitting is done by optometrists or ophthalmologists trained in special contact lens fitting, following the fitting principles that are appropriate to achieve natural symmetry, eyelid function, eye movements of BioEyes at all gazes. The target and result of those persons using BioEye is to have seamless routine of every day life on every task.
Mimic nature with multi layer 3D manufacturing process
The aesthetic parts of BioEye are custom manufactured fro every patient with only focusing on natural ocular structure.Iris is a foldable tissue of which three dimensional structure is enhanced be the cornea and aqueous, forming a magnifying lens. The scleral white part of the globe takes it's colour from underlying tissues with extra characteristics of the veins and the individual minor details.
With the exact same way theses aesthetic parts of BioEye are manufactured in 50 to 60 layers, to mimic natural structure from special colours made of the same material, pmma. In this way, following the natural tissue anatomy, aesthetic symmetry is achieved in any light conditions.
