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510(k) Data Aggregation
K Number
K150293Device Name
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
Manufacturer
I-SEE VISION TECHNOLOGY INC.
Date Cleared
2015-04-15
(68 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
I-SEE VISION TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZvue UV (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity.
The EZvue Colors (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Device Description
The EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19.
The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives: C.I. Reactive Blue 19, C.I. Pigment Green 7, Iron oxides, C.I. Reactive Yellow 86, C.I. Reactive Black 5, C.I. Pigment Violet 23, Titanium dioxide. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm.
In the hydrated state, both lenses conform to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface.
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K Number
K082879Device Name
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Manufacturer
I-SEE VISION TECHNOLOGY INC
Date Cleared
2009-06-16
(260 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
I-SEE VISION TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZvue (Ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity..
Eye care practitioners may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Device Description
EZvue (Ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear are available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photopolymerization. The EZvue (Ocufilcon D) lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packs containing sterile isotonic phosphate buffered saline.
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K Number
K082880Device Name
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
Manufacturer
I-SEE VISION TECHNOLOGY INC
Date Cleared
2009-06-16
(260 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
I-SEE VISION TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lens for daily wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Device Description
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photopolymerization. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
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K Number
K082883Device Name
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
Manufacturer
I-SEE VISION TECHNOLOGY INC
Date Cleared
2009-06-16
(260 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
I-SEE VISION TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity..
Eyecare practitioners may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Device Description
EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 38% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The EZvue (Polymacon) Contact lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
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