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  1. Consumer Updates

Focusing on Contact Lens Safety


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Approximately 45 million Americans wear contact lenses. In addition to offering flexibility, convenience, and a “no-glasses” appearance, contacts help correct a variety of vision disorders, including nearsightedness, farsightedness, astigmatism, and poor focusing with reading material.

But contact lenses also present potential risks. Contact lenses are worn directly on your eyes and can lead to serious eye infections and corneal ulcers (sores). The risk of getting these problems are greatly increased if you don’t care for the lenses properly—and if you don’t wear them properly. In rare cases, these conditions can lead to blindness.

The U.S. Food and Drug Administration regulates all contact lenses as prescription medical devices. Best strategies for reducing your risk of infection involve proper hygiene; following recommended wearing schedules; using proper lens care practices for cleaning, disinfecting and storing your lenses (which includes reading and following all product labeling instructions); and having routine eye exams.

The Federal Trade Commission (FTC) regulates device advertising and marketing practices that cause or are likely to cause substantial consumer injury.

Types of Contact Lenses

General Categories

  • Soft contact lenses. These are made of flexible plastics that allow oxygen to pass through to the cornea. Users get used to wearing them within several days. Most soft-contact wearers are prescribed with some type of frequent replacement schedule. An example of this is a schedule that calls for the lenses to be replaced with new ones after two weeks of use.
  • Rigid gas permeable (RGP) lenses. These products are durable, resist deposit buildup, and generally allow for clear, crisp vision. They last longer than soft contacts, and also are easier to handle and less likely to tear.

Specific Types

  • Extended wear contacts. These are good for overnight or continuous wear ranging from one to six nights, or up to 30 days. They can be either soft or rigid gas permeable lenses. It’s important for your eyes to have a rest without lenses for at least one night following each scheduled removal.
  • Daily wear contacts. These are made only to be worn while awake. Do not sleep in these lenses.
  • Disposable (or “replacement schedule”) contacts. As defined by the FDA, “disposable” means used once and discarded. With a true daily-wear disposable schedule, a brand new pair of lenses is used each day. However, some soft contacts referred to as “disposable” by sellers are actually daily wear lenses used for up to two weeks before being discarded.
  • Lenses designed for “Ortho-K.” Orthokeratology (Ortho-K) is a lens-fitting procedure that uses specially designed RGP contact lenses to change the curvature of the cornea to temporarily reduce nearsightedness. The most common type is overnight Ortho-K in which the lenses are worn only overnight, while sleeping. They are removed on awakening and improved vision is generally maintained through the day without the need for wearing glasses or contact lenses for nearsightedness. However, the lenses need to be worn nightly to maintain the correction.
  • Decorative contacts (also called “costume,” colored,” “fashion,” or “plano” contacts). The FDA has often warned people about the serious risks (including eye infection and blindness) associated with wearing these lenses without a prescription and the appropriate professional involvement. These lenses often don’t correct vision problems, in which case they are intended solely to change the appearance of the eye. If you want to wear these contacts, get a valid prescription (see the section below). You need a prescription even if you have perfect vision. And find more safety tips on FDA’s website.

The Need for a Prescription

You should have a prescription for any contact lenses, as contact lenses are not “one size fits all.” When you get an eye exam, you have the right to get a copy of your prescription.

Per FTC regulations, a prescription should contain sufficient information for a seller to completely and accurately fill the prescription: examination date; date you received the prescription after a contact lens fitting; expiration date; and the name, address, phone and fax number of the prescribing professional.

The prescription should also offer information about material and/or manufacturer, base curve or appropriate designation, and diameter (when appropriate) of the prescribed contact lens.

Tips for Buying

With a valid prescription, it is possible to purchase contact lenses from pharmacies, optical retailers, and online optical retailers.

However, contact lenses are NOT over-the-counter (OTC) devices. Companies that sell them as such are misbranding the device and violating FTC regulations by selling contact lenses without having your prescription. Contact lenses sold without a prescription from unlicensed vendors such as certain online distributors, novelty stores or tattoo parlors may be contaminated and/or counterfeit and therefore not safe to use.

Also keep the following tips in mind:

  • Make sure your prescription is current. Don’t order with an expired prescription, and don’t stock up on lenses right before the prescription is about to expire. If you haven’t had your eyes checked within the last year or two, you may have eye problems that you are not aware of, or your lenses may not correct your vision well. (The expiration date for your prescription is typically set by your state, which may require renewal in one or two years. If your state has not set a prescription expiration date then, by federal regulation, your contact lens prescription expires not less than one year after the prescription’s issue date. A prescriber may set a prescription date shorter than one year if the prescriber documents in your record the medical reasons justifying a shorter expiration date.)
  • Order from a supplier that you are familiar with and know is reliable. Reliable suppliers always require a valid, up-to-date prescription from your eye care provider. Talk to your eye care provider if you have questions or need a recommendation.
  • Request the manufacturer’s written patient instructions for use for your contact lenses. It will give you important risk/benefit information and instructions for use.
  • Make sure that you get the exact brand, lens name, power, sphere, cylinder (if any), axis (if any), diameter, base curve, and peripheral curves (if any) noted on the prescription. If you think you’ve received an incorrect lens or brand, check with your eye care professional. (The correct brand is important because there are differences in the water content and shape among the brands.) Don’t accept any substitution unless your eye care professional approves it.

How to Avoid Infection or Injury

Contact lens users run the risk of infections such as pink eye (conjunctivitis), corneal abrasions, and eye irritation. A common result of eye infection is corneal ulcers, which are open sores in the outer layer of the cornea. Many of these complications can be avoided through everyday care of the eye and contact lenses.

To reduce your chances of infection:

  • In general, if you’re using multipurpose contact lens solution, replace your contact lens storage case at least every 3 months or as directed by your eye care provider. If you’re using contact lens solution that contains hydrogen peroxide, always use the new contact lens case that comes with each box—and follow all directions that are included on or inside the packaging.
  • Clean and disinfect your lenses properly. When using contact lens solution, read and follow all instructions on the product label to avoid eye injury. This is particularly important if your eye care professional has recommended a solution with hydrogen peroxide, as these solutions require special care.
  • Always remove contact lenses before swimming.
  • Never reuse any lens solution. Always discard all of the used solution after each use, and add fresh solution to your lens case.
  • Do not expose your contacts to any water (which includes lake, pond, and ocean water as well as distilled water, tap water, and homemade saline solution) because it can be a source of microorganisms that may cause serious eye infections. (Contact lens solution is sold in “sterile” containers, which means it is free from living germs or microorganisms.)
  • Never put your lenses in your mouth or put saliva on your lenses. Saliva is not sterile.
  • Never transfer contact lens solutions into smaller travel size containers. These containers are not sterile, and unsterile solution can damage your eyes.
  • Do not wear contact lenses overnight unless your eye care provider has prescribed them to be worn that way. Any lenses worn overnight increase your risk of infection. Wearing contact lenses overnight can stress the cornea by reducing the amount of oxygen to the eye. They can also cause microscopic damage to the surface of the cornea, making it more susceptible to infection.
  • Never ignore symptoms of eye irritation or infection that may be associated with wearing contact lenses. These symptoms include discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, gritty feelings, unusual redness, blurred vision, swelling, or pain. If you experience any of these symptoms, remove your lenses immediately and keep them off. Contact your eye care professional immediately. Keep the lenses, because they may help your eye care professional determine the cause of your symptoms.
  • Report serious eye problems associated with your lenses to FDA’s MedWatch reporting program.

How to Report Problems

Here’s how you can help:

  • If you find a Web site you think is illegally selling contact lenses over the Web, you should report it to the FDA.
  • If you don’t get the exact lenses you ordered, report the problem directly to the company that supplied them.
  • To file a complaint about prescribing practices to FTC, use the FTC Consumer Complaint Form.
  • Consumers should report any problems with decorative contact lenses to their local FDA Consumer Complaint Coordinator. Any adverse reactions experienced with the use of these products, and/or quality problems should also be reported to FDA’s MedWatch Program.
 

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