(205 days)
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 1.00D or less of astigmatism.
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism is indicated for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may have 4.00D or less of astigmatism
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.
The Deseyne (vifilcon C) Daily Disposable Soft (hydrophililic) Contact Lenses with UV Blocking are manufactured in spherical or toric configurations. The lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2v1)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocvanine) to make the lens more visible for handling.
The provided text describes the acceptance criteria and the study that proves the device meets them for the "Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism."
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with corresponding performance for all aspects. Instead, it lists various evaluations and states that the device "meets or exceeds all properties and tolerances associated with each test conducted" or that endpoints were "met in accordance with the definitions of the protocol."
However, we can infer some key criteria and performance from the "Material Properties" section and the study results:
| Feature/Criterion | Acceptance Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Optical Characteristics (Myopia & Hyperopia Lens) | ||
| Powers | From -20.00D to +20.00D | From -20.00D to +20.00D |
| Cylinder | none | none |
| Axis | none | none |
| Base Curve | 8.60 | 8.60 |
| Diameter | 14.10 | 14.10 |
| Center Thickness | 0.05 | 0.05 |
| Optic Zone | 10.00 | 10.00 |
| Optical Characteristics (Astigmatism Lens) | ||
| Powers | From -20.00D to +20.00D | From -20.00D to +20.00D |
| Cylinder | From -1.00D to -3.50D | From -1.00D to -3.50D |
| Axis | From 5° to 180° with 5° step | From 5° to 180° with 5° step |
| Base Curve | 8.50 | 8.50 |
| Diameter | 14.40 | 14.40 |
| Center Thickness | 0.08 | 0.08 |
| Optic Zone | 8.00 | 8.00 |
| Tolerances | ||
| Powers | 0.00 D ~ ± 10 D, ± 0.25 D; ± 10.12 D ~ ± 20 D, ± 0.50 D | Device is designed to meet these, "meet or exceed all properties and tolerances" |
| Base Curve | ± 0.20 mm | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Diameter | ± 0.20 mm | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Center Thickness | ± 0.010 mm + 10% | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Surface Appearance | No Surface Defect, No Edge Defect, No Bubble | Device is designed to meet this, "meet or exceed all properties and tolerances" |
| Physical Properties | ||
| Refractive Index | Implicitly similar to predicate (1.40) or within acceptable range | 1.403 |
| Light Transmittance | >90% | >90% |
| UV Transmittance | τUVB |
§ 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.