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August 23, 2007

State Regulators Crack Down on Flea Market Sales of Colored Contact Lenses
Lenses sold without a prescription and fitting could be dangerous to consumers

CHICAGO – The Illinois Department of Financial and Professional Regulation (IDFPR) is serving Cease and Desist orders to beauty supply stores and flea market vendors selling cosmetic, colored contact lenses without a prescription.  The orders immediately stop the vendors from selling the lenses and could subject them to civil penalties of $10,000.  Colored lenses purchased without proper examinations and fittings put thousands of Illinois customers at risk of scratches, infections and potential blindness. 

“Young people and their parents need to be aware that a prescription and proper fitting by a licensed professional is mandatory, even for colored, cosmetic contact lenses.  Good vision and eye health is too important to risk because of a desire for different colored eyes,” said Dean Martinez, Secretary, IDFPR.  “Protecting consumers from unnecessary danger of infection is an important part of our responsibility as regulators.”

Only eye care professionals licensed in Illinois are authorized to prescribe contact lenses.  Without a prescription it is against the law to sell lenses. There are almost 2,000 licensed optometrists in Illinois and many have reported seeing patients who have suffered from infections or corneal scratches as a result of contact lens problems.  Because contact lenses sit directly on the cornea and limit the amount of oxygen reaching the eye, all contact lenses pose some risk to wearers.  By requiring lenses to be fitted and sold by professionals, that risk is limited and managed. All other sales of contact lenses to consumers are considered the unlicensed practice of optometry and subject to cease and desist orders and civil fines of up to $10,000.

“Stopping unlicensed practice is always a challenge, but by imposing the maximum allowable fine in each case, we hope to gain the attention of retailers who are breaking the law but find the profits hard to give up,” said Daniel E. Bluthardt, Director of the Division of Professional Regulation, IDFPR. “We will continue to invest resources into cutting off the supply of cosmetic contact lenses and hope to see a reduction in the number of infections as a result.”

 In addition to scratches from ill fitting lenses, another factor that makes this health threat so pressing is that bacteria build within the eye very rapidly.  Some types of bacteria can cause permanent scarring within twenty hours of the outbreak, if left untreated.  Additionally, students with irritated eyes have on occasion been misdiagnosed with pinkeye, an easily treated eye infection.  However, contact lenses can cause eye ulcers which must be treated with strong antibiotic medicine.  If left untreated, ulcers can cause partial or total irreversible blindness.

In 2005, the Food, Drug and Cosmetic Act was amended to classify all contact lenses – including decorative ones – as medical devices under FDA’s regulatory authority.  Further, the US Food and Drug Administration does not recognize over-the-counter sale of contact lenses as legitimate or safe.  Contact lenses distributed without appropriate involvement by eye care professionals are now considered misbranded devices and their sale is subject to regulation by FDA. And, under Illinois law, there are no legal way to sell contact lenses without FDA approval and an IDFPR professional license in Illinois.

“In our clinic we see hundreds of complications from poorly fit contact lenses, especially in  high-school aged kids as a direct result of non-prescribed contact lenses  and improper use. These problems are painful and delayed treatment can be devastating,” said Dr. Louise Sclafani, OD. “Until we shut down the stores that sell these lenses to unsuspecting buyers, we’ll continue to treat kids who are at risk for serious, permanent damage to their vision.”
A 14-year-old boy came to our clinic in extreme pain.  His eye had been red and sore for several weeks and had gotten progressively worse. Prior to that, he bought a pair of colored contact lenses from a fashion store that would match his newly purchased outfit from the same establishment.   He was not given any instruction on how to wear them or how to take care of them. He slept in them one night after soaking them in tap water. The next day he had a red painful eye that did not get better after several weeks of treatment with antibiotics prescribed by his pediatrician. He had developed an infection of the cornea, otherwise known as a corneal ulcer, and an amoeba that is commonly found in tap water was eating away at his eye. He endured months of blurred vision, pain, and had to administer very strong eye drops hourly.  He missed  a lot of school, football practice and his eye was permanently damaged, all in an effort to turn those brown eyes blue.  

“Some students may see these as harmless, part of a costume or a fashion accessory, but that’s clearly not the case,” said State Superintendent of Education Christopher Koch. “We’ll be working with Public Health and Professional Regulation to get information to school districts so that they can make sure their students understand the risk of serious infection that these can pose.”  

 “Anytime you put something in your body, whether prescription medicines, braces or contact lenses, you need to make sure it's under the supervision of a licensed professional.  Those professionals will make sure you take the correct dosage of medication, that the braces aren't too tight and that your contact lenses fit properly.  Without this supervision, you put your health at risk,” said Dr. Eric E. Whitaker, Illinois Department of Public Health Director.

Because the health risk is serious and most of the customers seeking cosmetic contact lenses are teens and young adults, IDFPR is partnering with the Illinois State Board of Education and the Department of Public Health to alert teachers, administrators and health care professionals in every school district and county in the state about the serious health and vision problems facing young people and warning signs to look for in their students and patients. 

Over the past week, IDFPR has sent investigators to cities across the state to purchase colored, non-corrective contact lenses at beauty supply stores in Rockford, Chicago and Peoria and at a flea market in Chicago and intends to continue to pursue the unlicensed sale of cosmetic contact lenses.  Illinois residents are encouraged to notify state officials if they see lenses for sale at retail outlets that do not require a prescription from a licensed eye-care professional.  Consumers can file complaints at www.idfpr.com or by calling our consumer hotline number at 800.280-4149.


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