Contact Lenses Classified as Medical Devices by the FDA – Prescriptions Required for Purchase

October is Contact Lens Safety Awareness Month at Prevent Blindness, Created to Provide Consumers Tips to Protect Vision

According to the Centers for Disease Control and Prevention (CDC), an estimated 45 million people in the United States wear contact lenses.  Many consumers may not be aware that contact lenses are medical devices and are regulated by the U.S. Food and Drug Administration (FDA) through the Federal Food, Drug, and Cosmetic Act. Additionally, the FDA states that contact lenses are not over-the-counter (OTC) devices and companies that sell them as such are misbranding the device and violating FTC regulations by selling contact lenses without having a valid prescription.

Prevent Blindness has declared October as Contact Lens Safety Awareness Month to educate the public on the best ways to care for their eyes through safe use and care of contact lenses.  As Halloween approaches, many may be interested in using cosmetic contacts as part of a costume.

Prevent Blindness recommends the following tips for contact lens care:

    • Always visit an eye doctor to be fitted for contact lenses before use. And, always wear contact lenses under the supervision of an eye doctor.


    • Before handling contact lenses, always wash hands with soap and water, then rinse and dry them with a lint-free towel.


    • Minimize contact with water, including removing lenses before going swimming or in a hot tub.


    • Never sleep in contact lenses unless authorized by an eye doctor, as this may increase the risk of infection, according to a new report from the CDC.


    • Contact lenses should not be rinsed with or stored in water (tap or sterile water).


    • Wear and replace contact lenses according to the schedule prescribed by an eye care professional.


    • Keep the contact lens case clean and replace it regularly, at least every three months.


    • Do not re-use old solution or “top off” the solution in your lens case.


    • Do not use cracked or damaged lens cases. Lens cases can be a source of contamination and infection.


    • Never trade or share lenses.


    • Remove contact lenses if the eyes become red, irritated, or painful. If vision issues continue, contact an eye doctor immediately.


“Contact lenses can be a great alternative to eyeglasses for many, but we must do our part to make sure we are using and caring for them safely,” said Jeff Todd, president and CEO of Prevent Blindness.  “A visit to an eyecare professional must always be the first step before using any contact lenses, even for those that are only decorative.”

For more information on contact lens and/or Halloween eye safety, please call 1-800-331-2020 or visit

Download a copy of the contact lens press release.