D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES

K965052 · Wesley Jessen Corp. · LPL · May 14, 1997 · Ophthalmic

Device Facts

• Record ID: K965052
• Device Name: D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES
• Applicant: Wesley Jessen Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: May 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters. The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters. The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

Device Story

Hydrophilic contact lenses (phemfilcon A) containing UV absorber; intended for daily wear vision correction. Device input: patient refractive error/astigmatism profile. Operation: lens placed on eye by patient per practitioner prescription; daily cleaning/disinfection required. Output: corrected visual acuity. Benefits: vision correction and UV protection. Manufactured by adding UV absorber to polymerized rods, then lathing to specific spherical or toric configurations.

Clinical Evidence

Bench testing only. Data demonstrates equivalence of the rod-incorporation process for UV absorber to the previously approved in-molding process, confirming no adverse impact on physical, optical, or chemical properties.

Technological Characteristics

Material: phemfilcon A (hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate). Water content: 55%. Dk/L: 32.2 x 10^-9. Refractive index: 1.412. Specific gravity: 1.152. Form factor: hemispherical shell, 12.0-15.0 mm diameter, 7.80-9.00 mm base curve. Manufacturing: UV absorber added to polymerized rods, then lathed.

Indications for Use

Indicated for daily wear in aphakic/non-aphakic persons with non-diseased eyes; myopic or hyperopic; astigmatism correction 0.75 to 6.00 D (Toric) or 2.00 D or less (Spherical).

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

• D3 FreshLook LiteTint UV lenses

Reference Devices

• PMA P830037/S31

Submission Summary (Full Text)

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W

WESLEY JESSEN

MAY 14 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## K 965052

### General Information

A. Device Generic Name: DuraSoft 3 UV (phemfilcon A) hydrophilic contact lens

B. Device Trade Name: DURASOFT® 3 Spherical: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 OptiFit® Toric: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 UV Spherical: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 UV OptiFit®: Clear, LiteTint™, Colors, Colors Complements

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 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.

The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

017

WESLEY JESSEN CORPORATION 333 EAST HOWARD AVENUE DES PLAINES, ILLINOIS 60018-5903 TELEPHONE [phone]

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# Substantial Equivalence

Substantial equivalence is being claimed for the addition of the UV absorber into the D3 Optifit Toric and D3 Spherical Soft lenses on the basis of the sponsor's prior approval of D3 FreshLook LiteTint UV lenses. The primary change occurring with the daily wear versions is that the UV absorber is being added to polymerized rods for lathed cut lenses while the previous approval was for the addition of the same UV absorber in the molding process as an in-molding process. Test data demonstrates the equivalence of the two processes and that the processes have no affect on the physical, optical or chemical properties of the finished lenses, and that the final finished specifications of the lenses are not adversely affected.

The process of incorporating the UV absorber into the polymer rods has been adjusted as an additive before polymerization which differs little from the previously approved in-process molding technique for molding lenses.

The sponsor will add appropriate UV absorption curves and standard claims statements to its labeling, and will continue to extend the current shelf life expiration date of two years, based on a reference to an approved shelf life protocol under the sponsor's PMA P830037/S31 approved March 5, 1990.

# Device Description

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

## DuraSoft 3 UV Optifit Toric

| Chord Diameter: | 12.0 to 15.0 mm |
| Center Thickness: | 0.07 to 0.56 mm (varies with power) |
| Base Curves: | 7.80 to 9.00 mm |
| Powers: | -20.00 Diopters to +20.00 Diopters |

## DuraSoft 3 UV Spherical Lenses

| Chord Diameter: | 12.0 to 15.0 mm |
| Center Thickness: | 0.05 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 methylcrylate and 2-ethoxyethyl methacrylate. The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by adding the UV absorber to the polymerized rods. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configurations.

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The physical properties of the lenses are:

Specific Gravity: 1.152
Refractive Index: 1.412
Light Transmittance:
LiteTint: 95% minimum
Colors: 97% minimum
Surface Characteristics: Hydrophilic
Water Content: 55%
Optical Zone: (Colors): 5 mm
(LiteTint): 5 mm to 9 mm (varies with power)
Oxygen Transmissibility: Dk/L = 32.2 x 10⁻⁹ ml 0. cm at 35°C
sec ml mm Hg

## General Use Instructions

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic or spherical lenses, respectively. The lens wearing schedule may be prescribed for daily use at the direction of the eye care practitioner.