(200 days)
RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.
RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.
O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act as a refracting medium to focus light rays on the retina.
Here's an analysis of the provided text regarding the O->PERM 30A (sterafocon A) contact lens, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Criteria) | Reported Device Performance |
|---|---|---|
| Safety | Adverse Reactions (none reported) | "There were no lens related Adverse Reactions reported in the study." |
| Slit Lamp Findings (typical, no treatment required) | "All Slit Lamp Findings were typical... No slit lamp findings required treatment." | |
| Bioburden Level ( |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.