November 1 2012, a 19-year-old woman from the local college came into my office complaining of scratchy, painful, swollen eyes. As the story goes, she had purchased decorative contact lenses online to complement her Halloween costume. Although I’m sure she looked amazing, after a few hours of wearing the contact lenses, her eyes started hurting which progressed throughout the evening. By the next morning she was in my exam chair being treated for Iridocyclitis, a deep swelling of the eye tissues. Luckily, with treatment, she recovered without permanent damage.
Cases like this led the US government to establish regulation that define contact lenses, whether prescription or cosmetic, as medical devices with protections in place to safeguard the public. According to the FDA, “On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act.” Click here for more info >>
“Without a valid prescription, fitting, supervision, or regular check-ups by a qualified eye care professional, decorative contact lenses, like all contact lenses, can cause a variety of serious injuries or conditions. For example, lens wear has been associated with corneal ulcer, which can lead rapidly to internal ocular infection if left untreated. Uncontrolled infection can cause corneal scarring, which can lead to vision impairment, and in extreme cases, blindness or the loss of an eye. Other risks include conjunctivitis; corneal edema (swelling); allergic reaction; abrasion from poor lens fit; reduction in visual acuity, contrast sensitivity, and other visual complications that can interfere with driving and other activities.
Because of these risks, contact lenses, including decorative contact lenses that are non-corrective, are not safe for use except under the supervision of a practitioner licensed by law to direct the use of such devices. The Agency believes that these risks cannot be sufficiently controlled unless the wearer does the following under professional supervision:
- Obtains advice about using contact lenses;
- Has a valid prescription;
- Has the lenses fitted properly; and
- Remains under appropriate professional care for contact lens use.”
Unfortunately, even though the United States government has set in place regulations to control the illegal sale of contact lenses, overseas companies are still selling contact lenses that are being shipped into the country.