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510(k) Data Aggregation
K Number
K230910Device Name
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
Manufacturer
Acculens, Inc.
Date Cleared
2023-06-16
(77 days)
Product Code
HQD, MUW
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
Acculens, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmam's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy. ectodermal dysplasia), neurotrophic keratiis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the New Vision SC (tisilfocon A) Scleral Lens may concurrently provide correction of up refractive error.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with 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.
Device Description
The NewVision SC (tisilfocon A) Scleral Lens is a large diameter rigid gas permeable lens designed to vault over the cornea and rest on the conjunctiva overlying the sclera. The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens partly rests on the cornea, centrally or peripherally, and partly on the limbus or conjunctiva over the sclera. The NewVision SC and New Vision SC Daily Wear Ortho-K (tisilfocon A) Lenses are lathe cut from tisilfocon A, which is an FDA Group #3 fluoro-silicone acrylate material.
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