RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT

K962957 · Wesley Jessen Corp. · LPL · Oct 1, 1996 · Ophthalmic

Device Facts

• Record ID: K962957
• Device Name: RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT
• Applicant: Wesley Jessen Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity. The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eye care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

Device Story

Hydrophilic contact lenses (phemfilcon A) for daily wear; used for vision correction in aphakic/non-aphakic patients. Lenses are hemispherical shells; available in clear (LiteTint) or opaque (Colors) versions. Colors version features pigments (iron oxides, titanium dioxide, copper phthalocyanine, etc.) on front surface. Prescribed by eye care practitioners for single-use disposable or frequent replacement (1-14 days). Requires cleaning/disinfection for frequent replacement. Benefits include visual acuity correction and handling visibility (LiteTint).

Clinical Evidence

No clinical data. Evidence based on preclinical testing: cytotoxicity (agarose overlay), systemic toxicity (mice), and primary ocular irritation (rabbit).

Technological Characteristics

Material: phemfilcon A (copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate). Water content: 38%. Specific gravity: 1.176. Refractive index: 1.440. Oxygen transmissibility (Dk/L): 12.9 x 10^-9. Dimensions: 12.0-15.0 mm diameter, 7.80-9.00 mm base curve. Pigments: iron oxides, titanium dioxide, [phthalocyaninato (2-1)] copper, chromium oxide, carbazole violet, phthalocyanine green. Sterilization: Not specified.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic and non-aphakic patients with non-diseased eyes; myopic or hyperopic; astigmatism ≤ 0.75 D.

Regulatory Classification

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.

Predicate Devices

• DuraSoft 2 clear and tinted lathe cut soft contact lenses (N17-852)
• DuraSoft 3 FreshLook Colors and LiteTint Contact Lenses (P830037/S33)

Submission Summary (Full Text)

{0}

4/4

W

A Proud Heritage of Innovation

OCT 1 1996

K962957

333 E. Howard Avenue
Des Plaines, IL 60018-5903
Telephone [phone]

# SUMMARY OF SAFETY & EFFECTIVENESS

## General Information

A. Device Generic Name: DuraSoft 2 FreshLook phemfilcon A hydrophilic contact lens
B. Device Trade Name: DuraSoft 2 FreshLook COLORS and FreshLook LiteTint Contact Lenses
C. Manufacturer's Name: Wesley-Jessen Corporation
333 East Howard Avenue
Des Plaines, IL 60018
D. Contact Person: Mr. Richard Main
Regulatory Affairs
Phone: [phone]
Fax: [phone]
E. Device Common Name: contact lens for daily wear

## Indications for Use

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity.

The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eye care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

## Substantial Equivalence

DuraSoft 2 FreshLook Colors and DuraSoft 2 FreshLook LiteTint Soft (hydrophilic) Contact Lenses are substantially equivalent to other DuraSoft 2 clear and tinted lathe cut soft (hydrophilic) contact lenses previously marketed in the United States. Additionally, the subject contact lenses have the same characteristics and properties as the DuraSoft 2 clear and tinted lenses, as approved under NDA N17-852. The DuraSoft 2 FreshLook Colors and FreshLook LiteTint Contact Lenses (the subject lens) is manufactured using the identical manufacturing process as the DuraSoft 3 FreshLook Colors and LiteTint Contact Lenses, as approved under PMA P830037/S33 approved

16

{1}

January 31, 1994. In 1994 the FDA reclassified all daily wear soft (hydrophilic) contact lenses from Class III, Premarket Approval to Class II, Premarket notification. Class II calls for establishing devices as substantially equivalent to previously marketed devices of the same class. DuraSoft 2 FreshLook Colors and DuraSoft 2 FreshLook LiteTint Soft (hydrophilic) Contact Lenses have the same physical, optical and chemical characteristics of their predicate devices. Preclinical testing including testing for cytotoxicity using the agarose overlay method; systemic toxicity in mice; and a primary ocular irritation study in the rabbit have established that minor changes in formulation to enhance molding characteristics have no detrimental affect on the lens material as manufactured.

## Device Description

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

| Chord Diameter: | 12.0 to 15.0 mm |
| --- | --- |
| Center Thickness: | 0.08 to 0.56 mm (Varies with power) |
| Base Curves: | 7.80 to 9.00 mm |
| Powers: | -20.00 Diopters to +20.00 Diopters |

The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Regulations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling.

The physical properties of the lenses are:

| Specific Gravity: | 1.176 |
| --- | --- |
| Refractive Index: | 1.440 |
| Light Transmittance: | |
| FreshLook LiteTint: | 95% minimum |
| FreshLook Colors: | 97% minimum |
| Surface Characteristics: | Hydrophilic |
| Water Content: | 38% |
| Optical Zone (FreshLook Colors): | 5 mm |
| (FreshLook LiteTint): | 5 mm to 9 mm (Varies with power) |
| Oxygen Transmissibility: | $$ \frac{ \text{DK}}{ \text{L} = 12.9 \times 10^{-9} \, \text{ml O}_2 \, \text{cm @ } 35^\circ \text{C} } $$ |
| | sec ml mm Hg |

## General Use Instructions

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are available as Spherical Contact Lenses. The lens wearing schedule may be prescribed for either Disposable Daily Wear or Frequent Replacement Wear for daily use.

17

{2}

In the Disposable program, patients should be instructed to dispose of the lenses at each daily removal and to use lens care products only on an emergency basis.

In the Frequent Replacement Program, the lens wearing time prescribed by the eye care practitioner is for daily wear from 1 to 14 days. Each time the lens needs to be removed before the replacement time has elapsed, the lens must be cleaned, rinsed, and disinfected prior to placing it back on the eye. Wesley-Jessen recommends that the lens be discarded and replaced with a new lens every 2 weeks, or as recommended by the eye care practitioner. The eye care practitioner is encouraged to determine the wearing schedule based on the response of the patient.

000018