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SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. 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. SynergEyes™ KC (paflufocon D hem-iberfilcon A) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. 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. SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. 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. Duette™ (SiH) (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic, and astigmatic refractive error including presbyopia, in aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. 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. UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. 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. UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. 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.

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The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eves with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, non-diseased eyes with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eyes with astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using only a chemical (not heat) disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The SynergEves® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens-at the central optical portion of the lens corresponding to the cornea-and soft hydrophilic silicone-hydrogel skirt-straddling the limbus of the eye peripherally. The lenses are manufactured by lathe cutting process for custom Rx, and fabricated from petrafocon A (rigid, central portion) and hem-larafilcon A (soft, peripheral portion). The soft skirt is comprised of silicone hydrogel copolymer (hem-larafilcon A). The lens consists of 28% water and 72% (petrafocon A and hem-larafilcon A). The (petratocon A and hem-larafilcon A) names have been adopted by the United States Adopted Names Council (USAN). When placed on the human cornea, the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens acts as a refractive medium to focus light rays onto the retina. The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens incorporates a violet visibility tint in the rigid gas permeable center, and a UV absorber. The device is available in the spherical, aspheric, multifocal (progressive), post-surgical, & irregular cornea design configurations with the following properties: • Chord Diameter 13.0 mm to 25.00 mm • Center Thickness 0.050 mm to 0.500 mm • Base Curve 5.50 mm to 9.50 mm • Power Range (sphere) -25.00D to +25.00D • Add Power +1.00D to +4.00D The Physical properties of the lens are: Refractive Index (wet) RGP Center 1.442 Soft Skirt 1.435 Luminous Transmittance (tinted) (380nm to 780) 87% 97% Surface Character hydrophobic hydrophilic Water Content 28 ± 2% Specific Gravity 1.15 N/A Oxygen Permeability (revised Fatt method) 130 84 The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (petrafocon A hem-larafilcon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness. The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses. UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye: - in the power range of -20.00 to +20.00 diopters for sphere, - with center thickness from 0.16 mm to 0.39 mm - with base curves of 5.5 mm to 9.00 mm - with diameter of 14.50mm When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material. The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.

Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

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SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens corneal option surrounded by a soft hydrophilic silicone-hydrogel skirt (periphery) that straddles the limbus of the eye : - in the power range of -20.00 to +20.00 diopters for sphere, - . cylinder powers up to 6.00 diopters for astigmatism - with center thickness from 0.12mm to 0.30mm . - with base curves of 7.10mm to 9.00mm - with diameter of 14.50mm - Add Powers 1.00 to 4.00 (multifocal) This lens material for the rigid portion is petrafocon A, an upgrade high Dk silicone base RGP material, lathe cut, surrounded by soft hydrophilis silicone-hydrogel copolymer (hem-larafilizon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™ SiH Hybrid Contact Lens acts as a refracting medium to focus light rays onto the The device is available in the following indications: spherical, toric, and multifocal, with retina. spherical or aspheric surfaces in violet visibility tim the RGP center, and multing, will may device is substantially equivalent to the SyneryEyes™ A and M (paflufocon D hem-iberfilion A) Hybrid Daily Wear Contact Lens predicate devices manufactured by the sponsor, Synerglyes, Inc. The SynergEyes™ Sill Hybrid Daily Wear Contact Lens center is a highly oxygen permeable (Dk 130) rigid gas material of (petrafocon A). The soft skirt is comprised of silicone-hydrogel copolymer (hem-larafilcon A) of 33% water and 73% polymer. The junction between the rigid material is bound by a proprietary chemical bonding method.

SynergEyes"16 A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive crror including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10,00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes 106 PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20,00 D eves with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes TM - A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens

SynergEyes™ A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear fo rhte correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas pearmeable lenses. SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

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SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses. SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

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For use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 in eyes with astigmatism or irregular astigmatism up to 6.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEves™ PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a combination rigid gas permeable contact lens corneal optic portion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye : - in the power range of -20.00 to +20.00 diopters for sphere . - . in the range of 0.25 to 6.00 diopters cylinder - with center thickness from 0.18mm to 0.30mm . - with base curves of 7.10mm to 9.60mm . - with diameter of 14.50mm . The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material cleared under K051035 and K052675. There are no differences to the chemical composition, formulation, manufacturing process, packaging and sterilization as described in the referenced 510(k). This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic copolymer (hem-iberfilcon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™Hybrid Contact Lens acts as a refracting medium to focus light rays onto the retina. The device is available as a lathe cut contact lens in the following design for post surgical refractive errors and trauma: multi concentric zones in blue visibility tinted material. This device is equivalent to the SynergEyes™ A and M Hybrid Contact Lens is material design and composition, and the SoftPerm® hybrid RGP manufactured by Ciba Vision Corporation. The SynergEyes™ PS Hybrid Daily Wear Contact Lens center optical portion is a rigid gas permeable material of (paflulofon-D) polymer. TThe soft skirt is comprised of HEMA (hydroxyethylmethacrylate) of 27% water and 73% polymer. The junction between the rigid material and soft material is bound by a proprietary chemical bonding method.