Search Filters

Search Results

Found 42 results

510(k) Data Aggregation

    K Number
    K133176
    Device Name
    AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2014-01-29

    (104 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. AIR OPTIX® COLORS Toric (Iotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with 6.00 diopters (D) or less of astigmatism. AIR OPTIX® COLORS Multifocal (Iotraficon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and/or presbyonia in phakic or aphakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye. The lenses may be prescribed for frequent wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
    Device Description
    The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group V (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2006/Amd.1:2009. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, and phthalocyanine green. Lens designs for AIR OPTIX® COLORS (lotrafilcon B) lenses include spherical, toric, and multifocal lenses in the following parameter range: Power Range: -20.00D to +20.00D Center Thickness: varies with design and power (0.08 mm for -3.00D spherical) Diameter Range: 13.0 to 15.0 mm Base Curve Range: 8.0 to 9.2 mm Lenses have the following properties: Refractive index: 1.422 (hydrated) Light transmittance: > 95% (380 - 780 nm) Water content: 33% by weight in normal saline Oxygen permeability: 110 x 10 -11 (cm2/sec)(ml O2/ml x mm Hg), measured at 35°C (intrinsic Dk-Coulometric method) Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845 (labeled as buffered saline containing 0.2 % VP/DMAEMA Copolymer).
    Ask a Question
    K Number
    K123994
    Device Name
    DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2013-02-21

    (57 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. DAILIES® (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green. Nelfilcon A lens designs include spherical, toric, and multifocal lenses in the following parameter ranges: Power Range: -20.00D to +20.00D, Center Thickness: varies with design and power (0.10 mm for -3.00D spherical). Lenses have the following properties: Refractive index: 1.38, Light transmittance: ≥ 92% (@ 610 nm), Water content: 69% by weight, Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method). Lenses are supplied sterile in sealed blister-packs containing buffered saline.
    Ask a Question
    K Number
    K113168
    Device Name
    DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2012-03-30

    (155 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DAILIES TOTAL 1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism. DAILIES TOTAL 1® (delefilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. DAILIES TOTAL 1® (delefilcon A) multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less. The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The lens material is 33% water and 67% delefilcon A, a silicone containing hydrogel with added phosphatidylcholine. The core lens material containing 33% water transitions through a water gradient to a hydrogel surface layer that exceeds 80% water. Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling. Delefilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges: Diameter Range: 13.0 to 15.0 mm Base Curve Range: 8.0 to 9.2 mm Power Range: -20.00D to +20.00D Center Thickness: varies with design and power (0.09 mm for -3.00D spherical) Lenses have the following properties: Refractive index: 1.42 (hydrated) Light transmittance: ≥ 93% (@610 nm, -1.00D) Water content: 33% by weight in normal saline Surface water content: ≥ 80% Oxygen permeability: 140 x 10-11 [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method) Each lens is packaged in a foil-sealed plastic containing phosphate buffered saline solution with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly(acrylamide-acrylic acid) and are steam sterilized.
    Ask a Question
    K Number
    K083216
    Device Name
    CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2009-04-14

    (165 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green. Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges: - Power Range: -20.00D to +20.00D . - 0.010 mm for -3.00D spherical (varies with power) Center Thickness: . Lenses have the following properties: - 1.38 Refractive index: . - Light transmittance: approximately 96 %T . - Water content : 69% by weight . - Oxygen permeability 26 barrer - measured at 35°C (single point Dk-Polarographic method) Lenses are supplied sterile in sealed blister-packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
    Ask a Question
    K Number
    K073459
    Device Name
    CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2008-02-28

    (80 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CIBA VISION® (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. CIBA VISION® Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. CIBA VISION® Multifocal (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. CIBA VISION® Multifocal Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. CIBA VISION® spherical (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. CIBA VISION® toric (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism. CIBA VISION® multifocal (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism. CIBA VISION® multifocal toric (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. In addition, CIBA VISION® (lotrafilcon A) lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.
    Device Description
    The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lenses contain the color additive phathalocyanine blue, a light blue handling tint, which helps make them easier to see when handling. Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges: • Diameter Range: 13.0 to 15.0 mm • Base Curve Range: 8.0 to 9.2 mm • Power Range: -20.00D to +20.00D • Center Thickness: varies with design and power (0.08 mm for -3.00D spherical) Lenses have the following properties: - Refractive index: 1.4217 (hydrated) - Light transmittance: > 94 % - Water content : 33% by weight in normal saline - Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)} measured at 35°C (intrinsic Dk-Coulometric method) Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845. The lens material is 24% water and 76% lotrafilcon A, a fluoro-silicone containing hydrogel which is surface treated. Lenses may be clear or contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling. Lotrafilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges: - Diameter Range: 13.0 to 15.0 mm - Base Curve Range: 8.0 to 9.2 mm - Power Range: -20.00D to +20.00D - Center Thickness: varies with power (0.080 mm for -3.00D spherical) Lenses have the following properties: - Refractive index: 1.4271 (hydrated) - Light transmittance: > 94 % - Water content : 24% by weight in normal saline - Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method) Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845.
    Ask a Question
    K Number
    K072777
    Device Name
    CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2008-01-24

    (118 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
    Device Description
    The nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD). Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges: Power Range: -20.00D to +20.00D Center Thickness: 0.010 mm for -3.00D spherical (varies with power) Lenses have the following properties: Refractive index: 1.38 Light transmittance: approximately 96 %T Water content : 69% by weight Oxygen permeability . 26 barrer measured at 35°C (single point Dk-Polarographic method) Lenses are supplied sterile in sealed blister-packs containing buffered saline.
    Ask a Question
    K Number
    K062262
    Device Name
    CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2006-11-14

    (102 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CIBA Vision® (sifilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism. CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 10.00 diopters (D) or less of astigmatism. CIBA Vision® Multifocal (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism. CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 4.00 diopters (D) or less of astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eve care professional.
    Device Description
    The lens material is 32% water and 68% sifilcon A a fluoro-silicone containing hydrogel which is surface treated. Sifilcon B lens designs include spherical, toric, multifocal and multifocal toric in the following parameter ranges: Diameter Range: 12.0 to 15.0 mm Base Curve Range: 7.0 to 9.2 mm Power Range: -20.00D to +20.00D Center Thickness: 0.070 mm for -3.00D spherical (varies with power) Lenses contain the color additive Phthalocyanine Green (PCN Green), a light green handling tint, which makes them easier to see when handling. Lenses have the following properties: Refractive index: 1.43 (hydrated) Light transmittance: approximately 92 % Water content : 32% by weight in normal saline Oxygen permeability: 82 x 10 -11 [(cm2 /sec)(ml O2 /ml=mmHg)] measured at 35°C (intrinsic Dk-Polarographic method) Lenses are supplied sterile in sealed blister-packs containing isotonic phosphate buffered saline solution.
    Ask a Question
    K Number
    K041820
    Device Name
    SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2005-09-09

    (430 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProGuard™ Lens Case is indicated for storage of soft (hydrophilic) contact lenses with AQuify® Multipurpose Solution.
    Device Description
    Data indicate that lens cases are a significant source of microbial contamination. The ProGuard Lens Case is a contact lens storage case that is infused with silver to help minimize contamination on the lens case surface. Laboratory testing showed that the silver ions reduce bacterial growth of Pseudomonas aeruginosa and Citrobacter amalonaticus on the case surface after 24 hours. No significant reduction was observed in the ProGuard lens case with S.epidermidis, S. aureus, P. mirabilis and S. marcescens (2 isolates).
    Ask a Question
    K Number
    K050250
    Device Name
    AQUIFY MULTIPURPOSE SOLUTION
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2005-08-10

    (188 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AQuify® Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.
    Device Description
    Not Found
    Ask a Question
    K Number
    K050065
    Device Name
    FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2005-05-27

    (135 days)

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

    CIBA VISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eves. Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of presbyopia in not aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The lenses are to be prescribed for single-use daily disposable wear. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a sinqle use.
    Device Description
    The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) ONE-DAY CONTACT LENS are daily wear soft contact lenses intended for single use daily disposable wear. The Dailies lens is a spherical soft contact, Dailies toric lenses have a double thin zone design, and the Dailies Progressives lens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances. The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108. The physical properties of the lens are: - Refractive Index: 1.38 (hydrated) - Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00D; 0.15 at +3.00D) - Light Transmittance: 96% (approx) - Oxygen Permeability (Dk): [35° C, Fatt corrected] 26 x 10-11 (cm²/sec) (ml O2/ml x mm Hg) - Water Content: 69% by weight in normal saline
    Ask a Question

    Page 1 of 5