Bausch + Lomb said today that it won FDA 510(k) clearance for the use of Tangible Hydra-PEG contact lens coating on new devices, now cleared for use with lenses made from its Boston gas permeable materials.
The new clearance will allow the Bridgewater, N.J.-based company to use the coating on its Boston XO, Boston XO2, Boston EO and Boston ES lenses, including those used in the Zenlens scleral lens family.
“Specialty contact lenses and the ability to offer customizable solutions are important for patients with challenging visual needs. The availability of the Tangible Hydra-PEG coating with Bausch + Lomb specialty vision products will enable practitioners to offer patients additional solutions for their demanding visual requirements,” Dr. Maria Walker of the University of Houston College of Optometry said in a prepared statement.
The Tangible Hydra-PEG coating is a high-water polymer coating bonded to the surface of contact lenses, the company said. The Tangible coating comes from Tangible Science, which Bausch + Lomb inked a licensing agreement with last June.
“The approval of the Hydra-PEG coating technology allows eye care professionals to offer improved lens wettability when using some of our key Boston GP materials or Zenlens scleral lenses, which demonstrates our ongoing commitment to bringing advancements that help meet the challenging vision needs of this patient segment. We continue to provide eye care professionals innovative specialty contact lens materials and support through our Boston brand of products, which have been available for decades,” U.S. prez Joe Gordon said in a press release.
