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The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The lens may be disinfected using either a heat or chemical disinfection system. Eye Care Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing schedule, with cleaning, disinfection and scheduled replacement of the lens.

The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Timed Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of a silicone vinylcarbamate, N-vinyl pyrrolidinone, a siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in a sterile borate buffered saline solution. The lens is tinted blue with up to 300ppm of the color additive Reactive Blue Dye 246 [(1, 4-Bis[4-(2-methacry) oxyethyl) phenylamino] anthraquinone]. The color additive conforms with 21 CFR Part 73.3106.

The physical / optical properties of the lens are:
Specific Gravity: 1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. Y value - at least 95%
Water Content: 36%
Oxygen Permeability (Dk): 99 x 10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (Polarographic Method)

The BAUSCH & LOMB OxyCor (balafilcon A) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D
Toric (Cylinder): 0 to 10 Diopters
Toric Axis: 0° to 180°

Each BAUSCH & LOMB OxyCor (balafilcon A) Visibility Tinted Contact Lens is supplied in a glass vial container with a solution of borate buffered saline. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date. In addition to the above, toric lenses are marked with cylinder power and axis information.

This 510(k) submission (K972454) for the BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens does not contain the information requested in your prompt.

The document describes the device, its intended use, and states that preclinical and clinical testing were performed to demonstrate safety and effectiveness. However, it only provides a summary of preclinical testing results and does not detail the acceptance criteria or results of the clinical study in the way you've outlined.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for clinical endpoints.
• Sample size used for a test set or data provenance for a clinical study.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (beyond general "safety and effectiveness").
• Sample size for a training set.
• How ground truth for a training set was established.

The document mainly focuses on demonstrating substantial equivalence to predicate devices (BAUSCH & LOMB® Premier 90 and BAUSCH & LOMB Optima™ 38) based on physicochemical properties and a statement that preclinical testing showed the material is not toxic and extracts are not irritating.

To answer your request, clinical study data with specific acceptance criteria and detailed performance metrics would be required, which is absent from the provided 510(k) summary.

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