Contact Lens Products (cont.)

Medical Editor:

The vision correction effect is temporary. If Ortho-K is discontinued, the corneas will return to their original curvature and the eye to its original amount of nearsightedness. Ortho-K lenses must continue to be worn every night or on some other prescribed maintenance schedule in order to maintain the treatment effect. Your eye care professional will determine the best maintenance schedule for you.

Currently, FDA requires that eye care professionals be trained and certified before using overnight Ortho-K lenses in their practice. You should ask your eye care professional about what lenses he or she is certified to fit if you are considering this procedure.

Decorative (Plano) Contact Lenses

Some contact lenses do not correct vision and are intended solely to change the appearance of the eye. These are sometimes called plano, zero-powered or non-corrective lenses. For example, they can temporarily change a brown-eyed person's eye color to blue, or make a person's eyes look "weird" by portraying Halloween themes. Even though these decorative lenses don't correct vision, they're regulated by the FDA, just like corrective contact lenses. They also carry the same risks to the eye. These risks include:

FDA is aware that consumers without valid prescriptions have bought decorative contact lenses from beauty salons, record stores, video stores, flea markets, convenience stores, beach shops and the Internet. Buying contact lenses without a prescription is dangerous!

If you're considering getting decorative contact lenses, you should:

  • get an eye exam from a licensed eye care professional
  • get a valid prescription that includes the brand and lens dimensions
  • buy the lenses from an eye care professional or from a vendor who requires that you provide prescription information for the lenses
  • follow directions for cleaning, disinfection, and wearing the lenses, and visit your eye care professional for follow-up eye exams

FDA issued a guidance document, "Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers - Decorative, Non-corrective Contact Lenses" on November 24, 2006. This guidance document explains the recently enacted legislation which make all contact lenses, including decorative, non-corrective contact lenses medical devices. The document also gives instructions on how to provide comments and suggestions to FDA about this issue.



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