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510(k) Data Aggregation
K Number
K051095Device Name
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Manufacturer
OPTICAL CONNECTION, INC.
Date Cleared
2005-08-16
(110 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
OPTICAL CONNECTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. Then prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
Device Description
The 55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells, which cover the cornea and a portion of the adjacent sclera. The 55 UV Contact Lens is available in a single vision lens design, the 55 UV Toric Contact Lens is available in a double slab-off back surface design and the 55 UV Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound, 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]] ethyl methacrylate, has been incorporated into the lens polymer. Lenses are tinted using the color additive Pigment Blue 15, ([Phthalocyaninato(2-)] copper).
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K Number
K040900Device Name
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Manufacturer
OPTICAL CONNECTION, INC.
Date Cleared
2004-06-15
(70 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
OPTICAL CONNECTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.
Device Description
S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.
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