News and Advice on Myopia and General Eye Care for Patients and Professionals

The Risks of Wearing Non-Prescription Decorative Contact Lenses

Paragon Vision October 14, 2019 Nearsighted, CRT Lenses, Contact Lenses, Orthokeratology, FDA Approved, Myopia, Ortho-K, optometrist, Eye Doctor, lifestyle, safety, CRT, vision, nearsightedness, eye health, vision health, eyes, health


What are your plans this Halloween, what will you be? Maybe you will be a vampire or dress as one of your favorite fictional characters. Either way it can be tempting to vamp up your costume with affordable colored contacts. If you are wearing cosmetic contacts this year be careful about skipping the doctor appointment for a prescription pair. Doing so nullifies the very measures that were meant to protect your eyes from the risks of over-the-counter contact lenses.

There are currently 45 million Americans wearing contact lenses.1 While contact lenses have greatly improved quality of life for millions of people across the world, they’re also not without risk.

Contact Lenses are Regulated Medical Devices

Corrective contact lenses were first classified as a class III medical device by the FDA in 1976, alongside pacemakers and external defibrillators. But the past 20 years has seen the rise of non-corrective, decorative and cosmetic contact lenses that regulators likely never saw coming.

Accompanying the unregulated dispensing of contact lenses was a troubling increase in cases of microbial keratitis among contact lens users.2 Microbial keratitis is a vision threatening eye infection. This prompted the FDA in 2005 to classify all contact lenses, whether corrective, cosmetic or decorative, as medical devices that can only be sold with a valid prescription from a licensed eye doctor.3

But despite federal regulation, illegal contact lenses still manage to make their way to gas stations, flea markets, beauty salons, convenience stores and are available over the internet.4

These products don’t go through the rigorous process required for FDA approval, yet, 28% of those who use non-corrective contact lenses purchase them from questionable nonmedical sources without a prescription from their eye doctor.5

A big part of the problem is that the majority of users don’t know that contact lenses are actually regulated medical devices until they develop a serious complication. Vendors themselves believe that because decorative contact lenses don’t correct vision, they don’t require the same level of medical care.6

What users and vendors alike don’t realize is that contact lenses are regulated not because they are corrective or non-corrective, but because of the risks that come from wearing a lens that does not properly fit over a specific person’s cornea. The cornea is the clear structure at the front of the eye which allows us to see clearly. With a poor contact lens fit, the cornea can experience blood vessel growth and scaring.

Not a “One-Size-Fits-All” Purchase

If you’ve ever tried pants that were too tight, rest assured the experience is nothing compared to wearing ill-fitting contact lenses.

Whether you need corrective lenses for your vision or decorative lenses to spruce up your Halloween costume, you will need to undergo a comprehensive eye exam performed by an eye doctor.

During the exam, the eye doctor will perform a variety of tests to determine your visual acuity and suitability for contact lenses. The doctor will also measure the curvature of the cornea to ensure the best possible lens fit.

Skipping this exam is sight-threatening. Ill-fitting contact lenses can not only easily scrape the surface of the eye and cause severe pain and inflammation, they also provide the perfect breeding ground for infections. In the worst-case scenario, wearing ill-fitting contact lenses can lead to microbial keratitis, which is a major cause of blindness.7,8,9  All of this can occur within hours of wearing the contact lens.4

Over-The-Counter Contact Lenses and Contamination

The Risks of Wearing Non-Prescription Decorative Contact Lenses

When you talk about counterfeit and illegal medical devices or supplies, it’s safe to assume that they’re contaminated and will do more harm than good.

In 2017, the FDA tested over 300 unapproved and counterfeit non-corrective contact lenses and found that 60% of counterfeit lenses and 27% of unapproved lenses were positive for microbial contamination. At least 29 different brands were included, and 48% of them were tested positive for microorganisms associated with eye infections including microbial keratitis and bacterial endophthalmitis.10

Professional Guidance is Important

Proper medical guidance has been proven crucial in preventing contact lens-related complications. With Paragon CRT® Lenses, there’s no need to take a blind shot at your future.

Our specialty orthokeratology lenses are worn overnight while a patient sleeps and gently reshapes their cornea to focus light correctly on the retina. In the morning, the patient removes the lenses and can see clearly all day without the need for glasses or daytime contacts.

Since being approved by the FDA for nearsighted treatment in 2002, Paragon CRT® Lenses has helped people across 50 countries see their future without limits.11,12 Unlike glasses or traditional contact lenses, Paragon CRT® do not get in the way of an active lifestyle. Paragon CRT® due to FDA regulations can only be prescribed by a Paragon CRT® certified eye doctor.

This Halloween get your spook on with freedom from glasses and daytime contacts! We can’t provide cosmetic contacts, but Paragon CRT® can give you a Halloween free from the fear of breaking your glasses or losing a contact. If decorative contacts are a necessity to your costume stay safe by visiting an eye doctor first! 





[1] Center for Devices and Radiological Health. (n.d.). Decorative, Non-corrective Contact Lenses - Guidance. Retrieved from

[2] Contact Lens–Related Corneal Infections - United States, 2005–2015 | MMWR. (n.d.). Retrieved from

[3] Fashionable, Nonprescription Contact Lenses May Pose A Danger To Your Eyesight. (2003, October 14). Retrieved from

[4] Steinemann, T. L., Pinninti, U., Szczotka, L. B., Eiferman, R. A., & Price, F. W. (2003, 10). Ocular Complications Associated with the Use of Cosmetic Contact Lenses from Unlicensed Vendors. Eye & Contact Lens: Science & Clinical Practice, 29(4), 196-200. doi:10.1097/00140068-200310000-00002

[5] So, you want decorative contacts for Halloween? What to know. (n.d.). Retrieved from

[6] Berenson, A. B., Chang, M., Hirth, J. M., & Merkley, K. H. (2019). Use and misuse of cosmetic contact lenses among US adolescents in Southeast Texas. Adolescent health, medicine and therapeutics, 10, 1–6. doi:10.2147/AHMT.S196573

[7] Abdelkader, A. (2014). Cosmetic soft contact lens associated ulcerative keratitis in Southern Saudi Arabia. Middle East African Journal of Ophthalmology, 21(3), 232. doi:10.4103/0974-9233.134677

[8] Loh K, Agarwal P. Contact lens related corneal ulcer. Malays Fam Physician. 2010 Apr 30;5(1):6-8. PubMed PMID: 25606178; PubMed Central PMCID: PMC4170392.

[9] Ayesha, M. Z., Umi Kalthum, M. N., Jemaima, C. H., & Faridah, H. A. (2015). Night market contact lens-related corneal ulcer: Should we increase public awareness?. Malaysian family physician : the official journal of the Academy of Family Physicians of Malaysia, 10(1), 47–49.

[10] Land, A. D., Penno, K. L., & Brzezinski, J. L. (2017, 05). Identification of Microorganisms Isolated From Counterfeit and Unapproved Decorative Contact Lenses. Journal of Forensic Sciences, 63(2), 635-639. doi:10.1111/1556-4029.13553

[11] FDA Approval Letter

[12] Accounting Letter from internal CRT System - total lenses sold since 2002, 8/14/15