(67 days)
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may have 0.75D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light.
These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).
The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.
The subject device is made of a silicone hydrogel material containing an internal wetting agent and UV absorbing monomers. A combination of a benzotriazole UV absorbing monomer and a naphthopyran monomer (photochromic additive) is used to block UV radiation and dynamically absorbs visible light. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 316 nm to 380 nm for the entire power range.
Additionally, the photochromic additive absorbs visible light in the range from 380 nm to 780 nm to a minimum 84% transmittance in the inactivated (closed) state. The activated (open) state dynamically absorbs visible light dependent on the lens thickness and the level of UV and high energy visible (HEV) radiation to a minimum of 23% transmittance.
Here's a breakdown of the acceptance criteria and study information for the ACUVUE® (senofilcon A) Soft Contact Lens with Photochromic Additive, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" for clinical performance in a pass/fail format with numerical thresholds. Instead, it describes general safety and effectiveness. However, it does provide specific physicochemical properties with target values and the outcome of the clinical study regarding visual acuity and driving performance.
For physicochemical properties, the "Subject Device" column implicitly represents the reported device performance against the defined properties. For clinical performance, the statement "no evidence of driving performance or visual acuity concerns" indicates the device met the safety and performance expectations.
Table of Acceptance Criteria (or Expected Properties) and Reported Device Performance
| Property / Parameter | Acceptance Criteria (or Expected Value) | Reported Device Performance |
|---|---|---|
| Water Content | 38% | 38% |
| Refractive Index | 1.42 | 1.42 |
| Oxygen Permeability (Fatt, edge-corrected) | 103 x 10^-11 (cm2/sec)(mL O2/mL * mm Hg) | 103 x 10^-11 (cm2/sec)(mL O2/mL * mm Hg) |
| Oxygen Permeability (Fatt, non-edge-corrected) | 122 x 10^-11 (cm2/sec)(mL O2/mL * mm Hg) | 122 x 10^-11 (cm2/sec)(mL O2/mL * mm Hg) |
| Light Transmittance: Visible - closed form | 84% to 94% | 84% to 94% |
| Light Transmittance: Visible - open form | Minimum 23% | Minimum 23% |
| Light Transmittance: UVA (316 nm to 380 nm) |
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.