(115 days)
The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses 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 disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are subsequently tinted to achieve different colors using permanently listed color additives that conform to 21 CFR Part 73.3121. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Black 5, Reactive yellow 15, Reactive orange 78, Reactive red 180.
The Legacy (ocufilcon D) Performance-Tinted Contact Lenses are designed to aid visual performance in athletic settings. Legacy (ocufilcon D) Performance Tinted Contact Lenses enhance contrast in a wide range of outdoor light conditions. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280mm - 315nm), and >50% in the UVA range (316nm - 380nm).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations.
The Legacy (Ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses underwent a series of non-clinical tests to demonstrate their safety and effectiveness. Clinical testing was not required as the performance of ocufilcon D materials has been previously established.
1. Table of Acceptance Criteria and Reported Device Performance:
The following table summarizes the performance data for the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, compared against established standards or general expectations for contact lenses.
| Parameter | Acceptance Criteria (or Standard) | Reported Device Performance |
|---|---|---|
| Toxicology | ||
| In-Vitro Cytotoxicity | Non-toxic (in accordance with ISO 10993-5) | Non-toxic |
| Systemic Toxicity | Non-toxic (meets ISO 10993-11 requirements for systemic injection) | Non-toxic |
| Acute Ocular Irritation | No ocular irritation (in accordance with ISO 10993-10) | No ocular irritation |
| Compatibility | ||
| Solution Compatibility | Compatible with chemical disinfection systems currently marketed for soft (hydrophilic) contact lenses | Compatible with chemical disinfection systems |
| Shelf Life | Stable, sterile, and package integrity maintained over labeled expiration date | Stability, sterility, and package integrity maintained over labeled expiration date |
| Physicochemical & Mechanical Properties | Consistent with predicate device and established standards (e.g., ANSI Z80.20) | Consistent with predicate device and established standards |
| Chord Diameter | ±0.20 mm | Meets tolerance (range: 11.00 mm to 15.00 mm) |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | Meets tolerance (range: 0.05 mm to 0.15 mm) |
| Base Curve | ±0.20 mm | Meets tolerance (range: 7.00 mm to 10.0 mm) |
| Back Vertex Power (F'v) | When 0.00 1.50 D → ± 5° | Meets tolerance (range: 10° to 180°) |
| Multifocal Add Power | ±0.37 D | Meets tolerance (range: +0.25D to +4.00D) |
| Surface Appearance | Lenses should be clear with no surface defect | Clear with no surface defect |
| Oxygen Permeability (x 10⁻¹¹ (cm²/sec)(mlO2)/(ml x mmHg)) | ±20% of 19.6 | 19.6 |
| Light Transmission - Tinted (@ 380-780nm) | > 38% | > 38% (reported with ±5% tolerance) |
| Ultraviolet Radiation Transmittance (TUVB: 280-315 nm; TUVA: 316-380 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.