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510(k) Data Aggregation
K Number
K112302Device Name
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
Manufacturer
COOPER VISION, INC.
Date Cleared
2011-12-21
(132 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
COOPER VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with nondiseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in non-aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear (omafilcon A) Soft (hydrophilic) Contact Lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Device Description
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacrylate and 2-metacryloloyoxyethyl phosphorylcholine cross linked with ethylene glycol dimethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510ks.
Proclear Toric and Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are back surface toric.
Proclear Multifocal and Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eve that is astigmatic.
Proclear Sphere and Asphere: (omafilcon A) Soft (hydrophilic) Contact Lenses. The sphere lenses have spherical optical zone and asphere lens have an aspherical optical zone. This aspheric optical zone design (front surface) controls and limits the amount of longitudinal spherical aberration generated by the lens across the power range
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K Number
K032873Device Name
PROCLEAR COMPATIBLES MULTIFOCAL
Manufacturer
COOPER VISION, INC.
Date Cleared
2003-11-07
(53 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
COOPER VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lens may be disinfected using a chemical disinfection system.
Device Description
The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.
Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:
• Diameter: 14.2mm to 15.0mm
• Base curve: 8.0mm to 9.5mm
• Center Thickness: 0.15mm to 0.96mm varies with power
• Powers: -20.00 to +20.00 D
• Add powers: +0.50 to +4.00 D
The physical properties of the lens are:
- . Refractive Index: 1.38
- Light Transmittance . 62%
- Surface Character: Hydrophilic . ・
- Water Content ● ሬቶਅ the power of
- Oxygen Permeability . 27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)
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