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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.

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