Warning against Cosmetic Contact lens : Potential threat to Vision Health 2025

Warning against Cosmetic Contact lens

From the American Academy of Optometry and the American Academy of Ophthalmology Secretary for Quality of Care

This statement applies to anyone who may consider getting contact lenses without a proper prescription and/or without proper contact lens care.

Summary

Patients using cosmetic (costume, theater, colored, decorative) lenses from stores or websites without eye care professional supervision or prescriptions have experienced adverse events and complications, including vision loss and serious infections. Doctors, patients, and consumers should be aware that there is a federal statute stating that a contact lens seller cannot provide contact lenses to its customers without a valid prescription.¹ Stores or websites selling any contact lenses without requiring a prescription are engaging in illegal business activities that are subject to federal law enforcement. Furthermore, the contact lenses may be counterfeit and not FDA-approved, putting the user at further risk for complications leading to permanent vision loss.

When contact lenses are initially prescribed and dispensed, patients should be trained and supervised in proper contact lens wear, handling, and care. Patients should be aware that all contact lenses, even decorative and costume contact lenses, are medical devices and require an eye doctor’s prescription and supervision.²

Background

The peer-reviewed literature includes reports of patients receiving cosmetic contact lenses from unauthorized vendors associated with eye pain and infections causing vision loss, including two patients requiring corneal transplantation (replacing the cornea with donor tissue).^3-5 Another study showed that the relative risk of microbial keratitis (severe corneal infection of resulting in corneal scarring and permanent vision loss) related to contact lenses is significantly increased in patients wearing cosmetic contact lenses.⁶ In addition, these studies have noted that patients who acquire these cosmetic contact lenses are less likely to be educated on appropriate use and care.^3,6 The U.S. FDA evaluated over 300 cosmetic contact lenses and found that 60% of the counterfeit contact lenses and 27% of the unapproved contact lenses were found to have microbial contamination, and were a threat to consumer health and safety.⁷

The FDA and Centers for Disease Control and Prevention (CDC) have made recommendations for contact lens wearers regarding proper wear and lens care practices, which are incorporated into the recommendations below:^8,9

• Wash hands with soap and water, rinse thoroughly, and dry (lint-free method) before handling contact lenses every time.
• Do not sleep in your contact lenses unless instructed by your eye doctor.
• Never store your contact lenses in tap water, well water, distilled water, or any other liquid not approved by the FDA expressly for use with contact lenses.
• Keep water away from your contact lenses. Take contact lenses out before showering, swimming, or using a hot tub.
• Rub, rinse and store contact lenses in disinfecting solution each time you remove them.
• Rub and rinse the case with contact lens solution, dry it with a clean tissue, and store it upside down with the caps off after each use.
• Do not “top off” solutions. Use only fresh contact lens disinfecting solution in a clean case—never mix old and new solutions.
• Wear and replace contact lenses according to the schedule prescribed by your doctor.
• Follow the specific contact lens cleaning and storage guidelines from your doctor and the solution manufacturer.
• Keep the contact lens case clean and replace it every 3 months.
• Remove the contact lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.
• See your eye doctor yearly or as often as he or she recommends for contact lens examination.

These recommendations apply to both contact lenses prescribed for refractive error (vision correction) and for contact lenses that alter the appearance (or color) of the eye.^2,10-12

Recommendations

The American Academy of Ophthalmology and the American Academy of Optometry encourage consumers to understand the risks of using unprescribed costume contact lenses. The risks include adverse events, such as corneal abrasions, corneal ulcers and infections, including even potentially vision-threatening infections. Contact lenses, including colored contact lenses, Halloween-inspired designs and other holiday designs, require a prescription and supervision by an eye care professional and should never be shared with others. Remember, costume contact lenses require the same precautions as regular contact lenses.

References

1. Federal Trade Commission. Contact Lens Rule. 2016. ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/contact-lens-rule. Accessed October 5, 2018.
2. U.S. Food and Drug Administration. Consumer Products. Decorative Contact Lenses.  2006  https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071578.pdf  Accessed September 30, 2025.
3. Steinemann Tl, Pinninti U, Szczotka LB et al. Ocular complications associated with the use of cosmetic contact lenses from unlicensed vendors. Eye Contact Lens 2003; 29:196-200.
4. Steinemann TL, Fletcher M, Bonny AE et al. Over-the-counter decorative contact lenses: Cosmetic or Medical Devices? A case series. Eye Contact Lens 2005; 31:194-200.
5. Gagnon MR, Walter KA. A case of acanthamoeba keratitis as a result of a cosmetic contact lens. Eye Contact Lens.  2006; 32:37-8.
6. Sauer A, Bourcier T, French Study Group for Contact Lenses Related Microbial Keratitis. Microbial keratitis as a foreseeable complication of cosmetic contact lenses: a prospective study. Acta Ophthalmol 2011; 89:e439-42.
7. Land AD, Penno KL, Brzezinski JL. Identification of microorganisms isolated from counterfiet and unapproved decorative contact lenses. J Forensic Sci 2018; 63:635-9.
8. Centers for Disease Control and Prevention. Preventing Eye Infections When Wearing Contacts. 2025. https://www.cdc.gov/contact-lenses/prevention/index.html. Accessed September 30, 2025.
9. American Academy of Ophthalmology. Eye Health. Colored Contacts & Halloween Safety. https://www.aao.org/eye-health/halloween-cosplay-colorful-contacts-eye-safety. Accessed September 30, 2025.
10. American Academy of Ophthalmology. Over-the-Counter Costume Contacts May Contain Chemicals Harmful to Eyes. September 2024. https://www.aao.org/eye-health/news/costume-contacts-may-contain-chemicals. Accessed September 30, 2025.
11. American Academy of Ophthalmology. Four Risks of Colored Contacts. September 2024. https://www.aao.org/eye-health/tips-prevention/avoid-these-four-dangers-of-non-prescription-conta. Accessed September 30, 2025.

The article is for awareness purpose adapted from aaopt.org