DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI

K993935 · Wesley Jessen Corp. · LPL · Dec 21, 1999 · Ophthalmic

Device Facts

• Record ID: K993935
• Device Name: DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
• Applicant: Wesley Jessen Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear. DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, inis or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lenses may be prescribed for Daily Wear in not-aphakic and/or aphakic persons. The eye care practitioner may prescribe the lens for daily use with routine cleaning. rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eve.

Device Story

Hydrophilic contact lenses (phemfilcon A) for daily wear; lathe-cut manufacturing; available in spherical and toric designs; includes UV-absorbing monomer variants. Used by eye care practitioners to correct refractive errors or provide prosthetic/cosmetic management for ocular abnormalities. Patients perform daily cleaning, rinsing, and chemical disinfection. Lenses provide visual correction and UV protection; prosthetic versions offer ocular masking for cosmetic or therapeutic (occlusive) purposes.

Clinical Evidence

No clinical data presented. Substantial equivalence is based on the established safety and performance profile of the predicate device platform (PMA P830037 series) and bench testing of physical properties (specific gravity, refractive index, light transmittance, oxygen transmissibility).

Technological Characteristics

Material: phemfilcon A (copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate). Water content: 55%. Specific gravity: 1.178. Refractive index: 1.411. Oxygen transmissibility (Dk/L): 32.2 x 10^-9. Manufacturing: Lathe cut and polished. UV-absorbing monomer added to specific models. Disinfection: Chemical (non-heat) only.

Indications for Use

Indicated for daily wear in aphakic and non-aphakic patients for correction of myopia, hyperopia, and astigmatism (up to 2.0D for spherical, 6.0D for toric). Also indicated for prosthetic use to alter eye color or mask ocular abnormalities (corneal, iris, lens) in sighted or non-sighted eyes, and for occlusive therapy (diplopia, amblyopia, extreme photophobia).

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.

Reference Devices

• PMA P830037/S40
• PMA P830037/S41
• K982344
• K991550 (FreshLook Bifocal UV-absorbing contact lenses)

Submission Summary (Full Text)

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DEC 2 1 1999

K993935

# SECTION III

## 510(k) Product Summary

## DuraSoft® 3 and DuraSoft® 3 UV Spherical, and OptiFit® Toric Soft Contact Lenses

## A. Device Summary

- 1. Name and Address of Applicant:
Wesley-Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018

Contact Person:

Joseph Foos Vice President Scientific Affairs [phone] Phone: [phone] Fax:

## 2. Name of the Device:

DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Trade Name: Spherical Clear. Handling Tint. Colors. Complements and ColorBlends Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear.

> DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Toric Clear, Handling Tint. Colors OptiFit Complements and ColorBlends Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear.

Classification Name: Soft (Hydrophilic) Contact Lenses for Daily Wear.

D 3 and D 3 UV Contact Lenses. Common Name:

DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Proprietary Name: Spherical Soft (Hydrophilic) Contact Lenses.

> DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) OptiFit Toric Soft (Hydrophilic) Contact Lenses.

- 3. Identification of predicate device:
Same as above. The addition of intended use to include cosmetic correction of disfigured eyes does not change the name of the device.

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#### 4. Description of device:

The dimensions of DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Toric hydrophilic contact lenses in Clear, Colors, Complements, ColorBlends and Handling Tint are the same as approved in PMA 830037/S41 and K982344.

The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft® 3 UV (phemfilcon A) contact lenses are made by adding the UV absorber to the monomer mixture. The physical properties of the lenses are listed below. The light transmittance table has been added as approved for the Supplement No. 42 PMA P830037 and 510(k) K991550 (FreshLook Bifocal UV-absorbing (phemfilcon A) contact lenses). The data to support this table is available in Section X, Exhibit -3.

| Physical properties of the lenses: | |
|------------------------------------|----------------------------------------------------|
| Specific Gravity: | 1.178 |
| Refractive Index: | 1.411 |
| Light Transmittance: | |
| Handling Tint: | 95% minimum |
| Color: | 95% minimum |
| Surface Characteristics: | Lathed and polished |
| Water Content: | 55% |
| Optical Zone: | |
| Handling Tint: | 5 mm to 9 mm (varies with power) |
| Colors: | 5 mm |
| Oxygen Transmissibility (Dk/L): | 32.2 x $10^{-9}$ ml O2 cm at 35° C<br>sec ml mm Hg |

| Light Transmittance | a) Visible (600 nm)≥95%<br>b) UV (250-400 nm) † | | | |
|--------------------------------------------------------------------|-------------------------------------------------|-----|------------------|------|
| DuraSoft® 3UV with | UVA (315-380 nm) | | UVB (280-315 nm) | |
| Handling Tint | +2.00 | 0.6 | +2.00 | 3.1 |
| | -4.00 | 4.0 | -4.00 | 10.7 |
| | -3.00* | 2.3 | -3.00* | 7.3 |
| DuraSoft® 3UV with | UVA (315-380 nm) | | UVB (280-315 nm) | |
| Carbazole violet<br>in-monomer tint | +2.00 | 0.7 | +2.00 | 1.7 |
| | -4.00 | 2.7 | -4.00 | 5.2 |
| | -3.00* | 2.9 | -3.00* | 5.6 |
| † The referenced data was determined from "Methods for Determining | | | | |

The referenced data was determined from "Methods for Determining Ultraviolet Transmission of UV-blocking Contact Lenses," by Dr. H. Faubl, International Contact Lens Clinic, Vol. 25, no.5, 1998.

� Representative of the thinnest lens design.

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## B. Statement of Intended Use

#### Spherical

DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

### OptiFit Toric

DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear.

#### Prosthetic

DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, inis or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.

The lenses may be prescribed for Daily Wear in not-aphakic and/or aphakic persons. The eye care practitioner may prescribe the lens for daily use with routine cleaning. rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eve.

### C. Technological Characteristics of the Device and Comparison

The physical properties of the device have not changed. Reference PMA Supplement P830037/S40 and S041 for technological device characteristics of the DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Toric Soft (Hydrophilic) Contact Lenses submitted and approved by the agency.

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#### D. Device Manufacturing Section

#### 1. Facility:

The manufacturing of the DuraSoft® 3 and DuraSoft® 3 UV Clear, Handling Tint, Colors, Complements and ColorBlends Spherical and OptiFit Toric Contact Lenses is at the following facility:

Wesley Jessen - Cidra Operation Road 173, KM 1.1 Cidra, PR 00739

Establishment Registration No.: 2648694

Reference PMA Supplement P830037/S041 for the manufacturing of the DuraSoft® 3 and DuraSoft® 3 UV Spherical and OptiFit Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses. All device-manufacturing information submitted to the FDA in the PMA Supplement P830037/S40 & S41 is applicable to this submission.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Mr. Joseph F. Foos Vice President, Scientific Affairs Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018-5903

#### Re: K993935

Trade Name: DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical, and OptiFit® Toric Clear, Handling Tint, Colors, Colors Complements® and ColorBlends Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear (Prosthetic Use) Regulatory Class: II Product Code: 86 LPL Dated: November 18, 1999 Received: November 19, 1999

Dear Mr. Foos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Joseph F. Foos

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS STATEMENT

510(k) Number (if known)

DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Device Name: Toric Clear, Handling Tint, Colors, Complements and ColorBlends Soft (Hydrophilic) Contact Lenses (Lathe Cut) for Daily Wear

#### Indication for Use:

#### Spherical

DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

#### OptiFit Toric

DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear.

#### Prosthetic

DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking. either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.

The lenses are indicated for Daily Wear in not-aphakic and/or aphakic persons. The eve care practitioner may prescribe the lens for daily use with routine cleaning, ninsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eye.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Conference of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|------------------|----|
| | OR |
| Over-The Counter | |

(Division Sign-Off)

*K. Brown, Ph.D*

Division of Ophthalmic Devices

| 510(k) Number | K993935 |
|---------------|---------|
|---------------|---------|

[Signature]