Onefit Lenses Have FDA Approval for Dry Eye with Optimum Materials

Onefit Family of Scleral Lenses Have FDA 510(k) Clearance for Treatment of Dry Eye with Optimum Materials

Blanchard is pleased to announce that our Onefit family of scleral lenses, including our latest addition Onefit MED, now have 510(k) clearance from the FDA for therapeutic applications – including treatment of dry eye – when manufactured in Contamac’s Optimum Extra and Optimum Extreme, as well as Hexa 100 materials.  Contamac announced the 510(k) clearance, marking a major advancement in the treatment of eyes suffering from ocular surface conditions such as dry eye syndrome, Sjorgen’s syndrome, Graft-versus-Host disease, keratitis and so many more.

“Onefit, Onefit MED and Onefit Asian lenses are widely used for all cornea types – normal to highly irregular – providing optimal comfort, visual acuity and long-term corneal health” said Jean Blanchard, President of Blanchard Contact Lenses.  “With this FDA clearance, practitioners can feel confident that when ordering our Onefit scleral lenses in Optimum materials, they are offering their patients the most comfortable, effective and healthy lens.  If practitioners also elect to coat their lenses in Tangible Hydra-PEG, they will have the most wettable and lubricious lens surface solution for Dry Eye!”