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The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 1.25 Diopters.

Eye care practitioners may prescribe the lens 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 disinfection system.

The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.

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I am sorry, but based on the provided document, I cannot identify any information regarding acceptance criteria, device performance results, or details about a study that would include sample sizes, ground truth establishment, or expert qualifications.

The document is an FDA 510(k) clearance letter for "Toricolors (hioxifilcon D) Soft Contact Lenses," confirming its substantial equivalence to a legally marketed predicate device. It primarily discusses regulatory classifications, general controls, and compliance requirements. It also includes an "Indications for Use" section.

There is no mention of a clinical study, performance metrics, or statistical analysis that would typically be associated with proving a device meets specific acceptance criteria.

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