Search Results

The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.

Device Description

The UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 8.5 to 10,5 mm . 0.10 mm to 0.28 mm Center Thickness: . 7.0 to 8.5 mm Base Curve: . +12.00 D to-20.00 D Powers: . The physical/optical properties of the lens are: Specific Gravity 1.105 . 1.57 at 20°C Refractive Index: . 98.5% Light Transmittance: . Hydrophobic Surface Character: . 0.5% Water Content: . 19° (CLMA method) Wetting Angle: . Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) . at 35°C [Fatt method used for determination of oxygen permeability] 2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear The UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 12.0 mm to 14.0 mm Center Thickness: 0.10 mm to 0.28 mm Base Curve: 7.0 to 8.5 mm Powers: +12.00 D to-20.00 D Peripheral Curves: C, D, and E The physical/optical properties of the lens are: Specific Gravity 1.105 Refractive Index: 1.57 at 20°C Light Transmittance: 96.5% Surface Character: Hydrophobic Water Content: 0.5% Wetting Angle: 19° (CLMA method) Oxygen Permeability (Dk): 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) at 35°C *[Fatt method used for determination of oxygen permeability]

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format as performance metrics against predefined thresholds. Instead, it demonstrates substantial equivalence to a predicate device, implying that meeting or exceeding the predicate's characteristics constitutes acceptance. The "Comparison to Predicate Device" table serves as the primary source for this.

Parameter	UltraCon and UltraCon S (Reported Performance)	LifeStyle GP (Predicate Device Performance)	Note
Material	carbosilfocon A	telefocon B	Different material, but same classification. Non-clinical tests confirmed safety.
Material Classification	Hydrophobic Lens Group 2	Hydrophobic Lens Group 2	Same classification.
Indication for Use	myopia, hyperopia, astigmatism	myopia, hyperopia, astigmatism	Identical indications.
Water Content	0.5%	less than 0.5%	Comparable.
Light Transmittance	96.5%	96%	Comparable, slightly better.
Dk (35° C)	44 x 10⁻¹¹	43.5 x 10⁻¹¹	Comparable, slightly better.
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters	Identical.
Color	blue visibility	blue, green, brown, and gray	Different color options, but for visibility tint, not clinical performance.
Specific Gravity	1.105	1.126	Comparable.
Refractive Index	1.57 at 20° C	1.480 at 20° C	Different, but considered acceptable within the context of substantial equivalence.
Wetting Angle

Ask a Question

Ask a specific question about this device

Page 1 of 1