ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP

K030842 · Soflex Contact Lens Industries , Ltd. · LPL · Jun 6, 2003 · Ophthalmic

Device Facts

• Record ID: K030842
• Device Name: ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP
• Applicant: Soflex Contact Lens Industries , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.

Device Story

Soft (hydrophilic) contact lenses made of acofilcon A; intended for daily wear; used to correct refractive errors including myopia, hyperopia, presbyopia, and astigmatism; suitable for aphakic and non-aphakic patients; requires chemical disinfection system; prescribed by eye care professionals; patient self-applied.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Material: acofilcon A; Type: soft (hydrophilic) contact lens; Regulation: 21 CFR 886.5925; Product Code: LPL; Class II; Sterilization: chemical disinfection system.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, presbyopia, and astigmatism in aphakic or non-aphakic persons with non-diseased eyes.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Soflex Contact Lens IndustriesLtd. c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

JUN - 6 2003

Re: K030842

Trade/Device Name:

Eni - Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear, Eni -- Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear and Eni - Eye Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 14, 2003 Received: March 16, 2003

Dear Mr. Walls:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Kevin Walls, RAC

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Rakyi Rosenthal

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

Enclosure

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K030842 510(k) Number (if known): __________

Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Device Name: Lens for Daily Wear

> Eni-Eye Q (Acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear

Eni-Eye Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

- Indications for Use: The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.

The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jonsel W.C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices

K030842 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)