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Custom Stable Receives 510(k) Clearance From The FDA

May 15, 2017

Valley Contax is proud to announce that we recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for our Custom Stable line of scleral contact lenses indicated for the therapeutic management of several ocular conditions.

To achieve this goal, the Custom Stable, which was manufactured in the Contamac line of Ultra High Dk, low-wetting-angle materials, went through a detailed clinical evaluation. The lenses were shown to effectively fit the eyes of patients who suffer from a multitude of ocular conditions, and also achieved clearance for the management of dry eye syndrome. Indications include the management of conditions such as degenerations that lead to an irregular corneal shape (e.g., keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann’s nodular degeneration), dystrophies (e.g., Cogan’s dystrophy, granular corneal dystrophy, lattice corneal dystrophy), and corneal scarring. Indications also include post-surgery (e.g., corneal transplant, LASIK, radial keratotomy) use.

The lens may also be prescribed for the management of ocular surface diseases (e.g., dry eye syndrome, keratoconjunctivitis sicca [graft-versus-host disease, Sjögren’s syndrome, filamentary keratitis], limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable GP scleral lens is also indicated for correction of refractive error in persons with myopia, hyperopia, or presbyopia.

The clearance designated that eye-care practitioners may prescribe the lenses for frequent/planned replacement wear, assuming regular cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens-care system.