l)The American Academy of Ophthalmology (AAO) met with representatives of the Food and
Drug Administration (FDA) recently to provide 15 case studies collected that show adverse
affects from plano (colored) contact lenses distributed without a prescription. Two weeks
ago the FDA announced an aggressive plan to move to prevent the distribution of these
potentially dangerous products directly to consumers. Plans to file a complaint and
proceed to seize products that are being marketed and distributed without a proper
prescription or fitting by an eye care professional are underway. Retail shops contacted
by the FDA have voluntarily withdrawn the product. The AMC/NOMA leadership wrote to the
FDA in October in response to our members' concerns. On this same issue. The AMC/NOMA
pointed out to the FDA that in our state of Ohio, the Attorney General has issued a
warning to consumers considering the over-the-counter purchase of cosmetic contact lenses.
The news release issuing this warning to consumers included lenses without a prescription
or fitting and had to have a corneal transplant to save the vision in one of her eyes. The
AMC/NOMA strongly encouraged the FDA to continue to consider colored contact lenses a
medical device, not cosmetics. View the FDA's public health notice at http://www.fda.gov./cdrh/safety/declensenorx.pdf
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