Search Results

The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 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 eye care practitioners in consultation with their patients.

Eye care 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.

Eye care 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.

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from methafilcon A, which is a hydrophilic copolymer 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% methafilcon A and 55% water by weight when immersed in saline solution. The (methafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

The Sofclear Enhance (methafilcon A) Daily Wear Contact Lenses are available tinted to enhance or alter the apparent color of the eye. The lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Reactive Blue 21, Reactive Blue 19, Reactive Yellow 86.

The Sofclear Colors (methafilcon A) Daily Wear Contact Lenses are available printed to enhance or alter the apparent color of the eye. The lenses are printed with one or a combination of one or more of the following 'listed' color additives: Red Iron Oxide, Violet 23, Titanium Dioxide, Chromium Oxide Green, Blue 36.

The Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses include a tint (1,4-Bis[4-(2methacryloxyethyl)phenylamino]-9,10-anthraquinone) in the composition of the lens for ease of handling and visibility.

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >88% in the UVB range (280mm - 315nm), and >68% in the UVA range (316nm - 380nm).

The Sofclear Enhance, Colors, and Comfort (methafilcon A) Daily Wear Contact Lenses will be manufactured in the spherical design configuration.

This document describes the pre-market notification (510(k)) for Gelflex Laboratories' Sofclear Enhance, Sofclear Colors, and Sofclear Comfort (methafilcon A) Daily Wear Contact Lenses. The submission asserts substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical performance metric sense (e.g., sensitivity, specificity for a diagnostic device). Instead, it demonstrates performance by comparing physicochemical and mechanical properties to the predicate devices and by demonstrating safety through non-clinical testing. The "acceptance criteria" appear to be meeting established standards for contact lenses and comparability to predicates.

Ask a specific question about this device

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.

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.

This document describes the 510(k) premarket notification for EZvue UV and EZvue Colors Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices, thus avoiding the need for extensive new clinical studies.

Here's an analysis based on your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative benchmarks for device performance in a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical properties, material composition, and intended use. The "reported device performance" refers to these physical characteristics and the results of non-clinical testing.

Ask a specific question about this device