Refocus Group announced that it has submitted its final module to the U.S. Food and Drug Administration (FDA) for pre-market approval of the VisAbility Micro Insert System for presbyopia. The VisAbility Micro Insert System is the first and only presbyopic procedure performed outside the eye's line-of-sight, developed to restore near vision without any compromise to distance vision or depth perception, a potential drawback of other presbyopic treatments. The VisAbility procedure is performed in the sclera (white of the eye), so it does not alter the cornea or natural lens, preserving the eye for future refractive or cataract procedures. The VisAbility procedure is performed on both eyes and consists of inserting four, micro-thin inserts, smaller than a grain of rice, just below the surface of the sclera. The inserts are so small they can't be felt, and are unnoticeable to others in normal gaze. The outpatient procedure is performed with topical (eye drop) anesthesia. The VisAbility Micro Insert System has been refined with considerable advancements to both the design and surgical technique, which have made the procedure faster and more precise. Investigators report a procedure time of under 20 minutes, with the measurements and data collection required for the trial.