More than 30 million Americans use contact lenses, according to the Contact Lens Council. 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. "Because they are worn directly on the eye, they can lead to conditions such as eye infections and corneal ulcers," says James Saviola, M.D. He is the Ophthalmic and Ear, Nose and Throat Devices Network Leader in the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). "These conditions can develop very quickly and can be very serious. In rare cases, they can lead to blindness."
Heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide.
FDA approvals and oversight have made scientific and technological breakthroughs accessible, greatly expanding the number of people who can benefit from these devices.
FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of all medical devices, including heart devices, sold in the United States.
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, and having routine eye exams.
FDA regulates contact lenses through the Federal Food, Drug, and Cosmetic Act. The agency also regulates contact lenses—including those intended for vision correction and for decorative purposes—as prescription devices, and has jurisdiction over contact lens solution.
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
Soft Contact Lenses are comfortable and made of flexible plastics that allow oxygen to pass through to the cornea. Users get accustomed to wearing them within several days. Most soft-contact wearers are prescribed 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 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. However, they may take a few weeks of getting used to.
Extended Wear Contacts are good for overnight or continuous wear ranging from one to six nights, or up to 30 days. It's important for the eyes to have a rest without lenses for at least one night following each scheduled removal.
Disposable (Replacement Schedule) Contacts. To FDA, “disposable” means "to be used once and discarded." However, some soft contacts referred to as “disposable” by sellers are actually worn on a frequent replacement schedule--for two weeks, for example--that calls for them to be disinfected between uses.
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 improve the eye's ability to focus. It's primarily used for the correction of nearsightedness. The most common type is overnight Ortho-K, and FDA requires that eye care professionals be trained and certified before using them in their practices.
Decorative (Plano) Contacts. FDA has often warned people about the risks associated with wearing these lenses without appropriate professional involvement. They don't correct vision and are intended solely to change the appearance of the eye.