FDA Says Concise Safe and Effective

"Information presented in this Premarket Notification establishes that the Concise, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication." That's the conclusion of the Food and Drug Administration report. "The Concise Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry nhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint." Read more.