Search Results

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge to edge for visibility purposes with the color additive C. I. Reactive Blue 4.

The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.

The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available in two versions. The Proclear UltraVue/D 2000T with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision.

Both lenses are a flexible transparent hemispherical shell of the following dimensions:

• Chord Diameter: 14.5 mm
• Center Thickness (minus): 0.15 mm to 0.20 mm
• Center Thickness (plus): 0.20 mm to 0.96 mm
• Base Curve: 8.3 mm to 8.9mm
• Spherical Powers: -20.00 D to +20.00 D
• Cylinder Powers: -0.75 to -2.75 D
• Add Powers: +1.00 to +3.50
• Central Zone Diameter: 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T), 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T)

The provided text describes a 510(k) premarket notification for CooperVision's Proclear UltraVue Multifocal and Multifocal Toric Soft (hydrophilic) Contact Lenses. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a regulatory submission for substantial equivalence to a legally marketed predicate device, focusing on device description, intended use, and material/design comparisons, rather than a clinical performance study with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them based on the provided text. The requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not present in this document.

Ask a specific question about this device