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Are the Colored Contact Lenses You Purchased Really FDA-Approved?

Feb 10,2023 | Unicoeye® | Colored Contact Lenses

Want to act like a forest elf with green eyes? Want blue eyes to take your sweet makeup look to the next level? Or deep violet eyes to match your purple sweater? You can easily achieve these looks with colored contact lenses. But when you’re planning to use colored contact lenses, first and foremost, you need to make sure that the lenses you purchase are approved by the U.S. Food and Drug Administration (FDA), as this means that they meet the market’s established safety standards.


The FDA is responsible for regulating all colored contact lenses as prescription medical devices and requires colored contact lens vendors to be registered on their website. According to FDA guidelines, compliance with registration can facilitate the supervision of a vendor's products and allow consumers to report product-related problems and complaints. Therefore, confirming that your colored contact lenses have FDA approval is the first step to ensuring that they’re safe to use. So, how can you confirm that your colored contact lenses have FDA approval?


The first thing to note is that there is no certificate that verifies FDA approval. The FDA registration certificate placed on some brands’ websites does not at all prove that their products comply with FDA regulations. You can check the authenticity of a brand’s FDA registration information by performing the following steps on the FDA’s official website:


  1. Open the Establishment Registration & Device Listing page by going to the FDA home page and clicking Medical Devices > Databases > Registration & Listing, or by using the following link:
  2. Enter the brand name in the “Proprietary Name” search box.
  3. Check the registration details that appear. If the brand is not listed, then lenses from this brand are probably not FDA-approved.


By following these steps, you can confirm whether the colored contact lenses you want to wear are safe and approved by the FDA. We at Unicoeye, in addition to providing safe and FDA-approved lenses, also prioritize our customers’ vision health. We hope consumers take the time to confirm FDA approval for any colored contact lenses they’re considering buying, which will help them avoid any potential risks and harm associated with using poorly made lenses that are not approved by the FDA,  such as ocular scratches, corneal infection, impaired vision, and even blindness. Additionally, we urge all consumers never to buy contact lenses of any kind from:


  • Street vendors
  • Salons or beauty supply stores
  • Boutiques
  • Flea markets
  • Novelty stores
  • Halloween stores
  • Record or video stores
  • Convenience stores
  • Beachfront stores or gift shops


The types of establishments listed above are not authorized distributors of colored contact lenses, and it is even illegal for some of these vendors to sell them. Colored contact lenses sold by these establishments may not have been cleared or approved by the FDA and may even be unsterilized or harmful to the eyes.