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510(k) Data Aggregation

    K Number
    K023077
    Device Name
    OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2002-12-10

    (85 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Spherical Soft Contact Lens are indicated for daily wear for the correction of hyperopia in pediatric aphakic persons. The lens may be disinfected with chemical (not heat) disinfection system.
    Device Description
    The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Soft Contact Lens for Daily Wear (lathecut) is fabricated from ocufilcon B 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 aphakic lens designs are made for daily wear for the correction of refractive hyperopia in pediatric aphakic persons. The design elements of the OCU-FLEX PEDIATRIC APHAKIC (ocufileon B) Soft Contact Lens for Daily Wear (lathe-cut) is intended to accommodate pediatric patients. The lens design has a higher power range and smaller lens to compensate for the increased power. In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The non-ionic lens material, ocufilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) methacrylic acid and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 47% ocufilcon B and 53% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Reactive Blue 21.
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    K Number
    K020690
    Device Name
    OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2002-04-26

    (53 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical (not heat) disinfection system only.
    Device Description
    The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens is a partially or totally white opaque lens that can be painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The lens material (ocufilcon B) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate, methacrylic acid and cross-linked with ethylene glycol dimethacrylate, 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 approved pigment, titanium dioxide, is incorporated into the monomer during polymerization with the help of a coupling agent. The titanium dioxide is evenly distributed throughout the lens and cannot be extracted. The lens is available in opaque patterns including Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, and Solid Annular Opaque with Clear Pupil & Clear Edge.
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    K Number
    K011577
    Device Name
    OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2001-06-19

    (28 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The lens may be disinfected with chemical (not heat) disinfection system.
    Device Description
    The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon 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. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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. The ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution. The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design. The physical properties of the lens are: Refractive Index 1.4153 Light Transmission greater than 95% T Specific Gravity 1.090 g/cc Water Content 55% Color Pigment Name Phthalocyanine Blue Oxygen Permeability Dk=18x10-11 @ 35°C
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    K Number
    K003996
    Device Name
    OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2001-02-21

    (57 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K004000
    Device Name
    OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2001-02-21

    (57 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002966
    Device Name
    OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    2000-11-08

    (47 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992466
    Device Name
    OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    1999-10-04

    (73 days)

    Product Code
    LPL, DEV
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical or heat disinfection system.
    Device Description
    The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a hydrophilic polymer of 2-hydroxyethyl-methacrylate crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 38% water and 62% polymacon by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a spherical conic lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens design begins with a spherical 5.0mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then flattens into the base curve, which is considered the fitting curve of the lens. The cone curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with a peripheral curve to maintain alignment and comfort.
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    K Number
    K960291
    Device Name
    TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
    Manufacturer
    OCU-EASE OPTICAL PRODUCTS, INC.
    Date Cleared
    1996-03-25

    (63 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCU-EASE OPTICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    indicated for use as a daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes.
    Device Description
    Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version.
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