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510(k) Data Aggregation
K Number
K152724Device Name
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
Manufacturer
Date Cleared
2016-04-27
(218 days)
Product Code
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED VISION TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Device Description
The EvePrintPRO (roflufocon D) Scleral GP Lens is a rigid gas permeable (RGP) lens designed from measurements of the ocular surface obtained by the EyePrint Impression Process. The vinyl polysiloxane (VPS) impression material used for the EyePrint Impression process is Panasil Initial Contact Light, with 510(k) clearance under K083701. The lenses are manufactured from the hydrophobic contact lens material (roflufocon D). When placed on the human cornea, the EvePrintPRO RGP lenses act as a refracting medium to focus light rays upon the retina.
The EyePrintPRO (roflufocon D) Scleral GP Lenses are available as lathe cut lenses manufactured from (roflufocon D) optical blanks, which incorporate a handling tint using the following FDA listed color additives: D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18.
In the EyePrintPRO (roflufocon D) Scleral GP Lenses with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2,2'-Dihydroxy-4,4'dimethoxybenzophenone.
The UV blocking for EyePrintPRO (roflufocon D) Scleral GP Lenses averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380nm.
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K Number
K121324Device Name
AVT NATURASOFT
Manufacturer
Date Cleared
2012-08-23
(113 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED VISION TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The AVT NATURASOFT, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.
The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners are to prescribe the lenses for quarterly 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 or hydrogen peroxide disinfection systems.
Device Description
The AVT NATURASOFT Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) 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. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
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