CONTACT LENS WITH COLOR ADDITIVE

K962911 · Cal Bionics · LPL · Nov 29, 1996 · Ophthalmic

Device Facts

• Record ID: K962911
• Device Name: CONTACT LENS WITH COLOR ADDITIVE
• Applicant: Cal Bionics
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Cal Bionics daily wear soft (hydrophilic) contact lens with visibility tint is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The lens is intended for daily wear.

Device Story

Soft (hydrophilic) contact lens manufactured from methafilcon-A (55% water content); incorporates FDA-approved colorant for visibility tinting. Lathe-cut from blanks at approved sites. Used by patients for vision correction; visibility tint aids handling/cleaning. No change to eye appearance. Cleaning regimens identical to clear lens counterparts.

Clinical Evidence

Bench testing only. No clinical data provided. Safety supported by history of use of methafilcon-A polymer since 1984 and ten-year history of Cal Bionics clear lens distribution with no reported adverse reactions.

Technological Characteristics

Material: methafilcon-A (55% water content). Form: soft (hydrophilic) contact lens. Feature: visibility tint via FDA-approved colorant. Manufacturing: lathe-cut from blanks. Sterilization: standard contact lens protocols.

Indications for Use

Indicated for correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes; includes patients with astigmatism ≤ 1.50 diopters. Daily wear only.

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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1777 INDIAN VALLEY ROAD, NOVATO, CALIFORNIA 94947 • [phone] • FAX [phone]

Cal Bionics

K962911

NOV 29 1996

# Summary of Safety and Effectiveness for Contact Lens with Color Additive.

The material from which the lens will be manufactured is FDA approved methafilcon-A. When fully hydrated, the material has a 55% water content. This high water content soft (hydrophilic) contact lens material has been tested for performance, comfort and oxygen transmissibility. Since 1984, it has been a widely employed polymer in the contact lens industry. There are many FDA approved manufacturers of soft contact lenses from this material.

Cal Bionics, Inc. received FDA Approval for our daily wear and extended wear soft contact lenses in 1986. In the ten years that our FDA approved daily wear and extended wear lenses have been distributed, there have been no reported adverse reactions or significant complaints. Cal Bionics, Inc. manufactures the contact lens blanks which are then supplied to our FDA approved Alternate Manufacturing Sites where the blanks are lathe cut into finished soft contact lenses.

We now intend to add a "visibility tint" to our daily wear lenses so that they can be seen more easily while being handled for cleaning. We intend to add to our contact lens blanks a small amount of a colorant approved by the FDA for use in contact lenses. The concentration of the colorant is within the range approved by the FDA for use of this colorant in lenses. The colorant concentration is so low that the finished contact lens appears to have just a very faint blue-green tint when held against a white background. The very faint tint of this lens does not change the apparent color of the wearer's eye.

The processes and equipment used to manufacture the "visibility tint" blanks and lenses are identical to those used for our clear daily wear blanks and lenses. The addition of the colorant does not affect the material in any way except for the addition of a faint color. The cleaning regimens already approved by the FDA for our clear lenses will apply to the tinted lenses. The parameters and indications for the tinted lenses are exactly the same as those approved by the FDA for our clear lenses.

It is believed that the addition of an FDA approved colorant, in concentrations approved by the FDA, to an FDA approved polymer will produce tinted lens blanks which will produce the safest of conditions when manufactured into soft (hydrophilic) contact lenses following these designs and parameters already approved by the FDA.

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.