Contact Lens Safety & FDA Compliance

At Gothika®, we have spent over 25 years providing the highest quality theatrical and cosmetic contact lenses. Because contact lenses sit directly on your eye, they are classified as medical devices by the United States Food and Drug Administration (FDA)—even if you are only wearing them to change your eye color for a costume.

Your vision and eye health are our top priorities. Below, you will find everything you need to know about our safety standards and how to care for your lenses.

1. FDA Cleared & Safe for Your Eyes

Never risk your vision with cheap, unverified counterfeit lenses. All Gothika® contact lenses are manufactured in state-of-the-art, federally regulated facilities. Our lenses are fully FDA-cleared, meaning they have undergone rigorous testing for material safety, sterility, and breathability.

2. The Prescription Verification Process

In compliance with the Fairness to Contact Lens Consumers Act (FTCLCA), we are required by law to verify your contact lens prescription before shipping your order—even if you are ordering “Plano” (0.00 / non-corrective) lenses.

How it works: During checkout, you will provide your eye care professional’s contact information or upload a valid prescription.
Why we do it: A proper fitting by an eye doctor ensures the base curve and diameter of the lens are safe for your specific eye shape, preventing painful corneal scratches or infections.

3. Essential Lens Care & Handling

Even the safest lenses require proper hygiene. Follow these essential rules to keep your eyes healthy and your Gothika lenses looking amazing:

Wash Your Hands: Always wash and dry your hands with a lint-free towel before touching your lenses or your eyes.
Inspect the Lens: Before inserting, check the lens on the tip of your finger. Ensure it forms a perfect “bowl” shape and has no tears or dried edges.
Use Proper Solution: Store and clean your lenses ONLY in fresh, sterile contact lens solution. Never use tap water, bottled water, or saliva, as these contain dangerous bacteria.
Never Share Your Lenses: Sharing contact lenses is a severe health risk and can lead to pink eye, corneal ulcers, and permanent vision loss.
Respect the Lifespan: Do not wear your lenses longer than the recommended duration (e.g., sleeping in lenses not designed for overnight wear), and replace them once they reach their expiration date.

4. When to Remove Your Lenses

If you experience any of the following symptoms, remove your contact lenses immediately and contact your optometrist or ophthalmologist:

Unusual redness or swelling
Pain, stinging, or burning
Excessive tearing or sensitivity to light
Blurred vision