Find out how to report illegal retailers, adverse events.

Illegal contact lens retailers slapped with fines, penalties

Authorities' undercover investigation nets more than three dozen Texas retailers illegally selling contact lenses, resulting in $140,000 in civil penalties and demonstrating the necessity of strict enforcement.

"It is evident that they recognize the importance of provider oversight as it pertains to contact lenses as medical devices."

State Attorney General Ken Paxton's Consumer Protection Division announced May 7 that it had secured Assurances of Voluntary Compliance from 37 store owners and distribution companies, capitalizing on a two-year undercover sweep of businesses selling contact lenses without prescriptions, in violation of the Texas Optometry Act and Texas Deceptive Trade Practices Act.

In 2016, the state attorney general's office and San Antonio Police Department uncovered more than two dozen novelty shops, corner stores and gas stations selling contact lenses sans prescriptions. Subsequent investigations determined these retailers were supplied by 10 companies located primarily in San Antonio, Houston and Dallas.

Police later determined these stores acquired contact lenses from vendors who allegedly stored the products in the back of vans, raising questions about how storage conditions affected these lenses' integrity.

"My office's contact lens sweep is a reminder to Texans to safeguard their vision by using only contact lenses prescribed for them by a licensed practitioner," Paxton commented in a news release. "We will continue to take appropriate action against retailers and businesses that endanger consumers by selling unlawful lenses. We strongly urge anyone who has found retailers selling lenses without a prescription to contact our office."

Contact lenses are a safe and effective vision correction option for nearly 40 million Americans, but there are myriad reasons why all contact lenses-whether corrective or decorative plano-are classified as medical devices by the U.S. Food and Drug Administration (FDA) and require a valid prescription to purchase: When improperly or carelessly worn, contact lenses can cause significant ocular damage or infection.

In fact, the Centers for Disease Control and Prevention (CDC) illustrated the toll of lax contact lens care in a 2016 Morbidity and Mortality Weekly Report:

  • 1 in 5 cases of contact lens-related infections result in corneal damage
  • 99 percent of contact lens wearers commit at least one unsafe hygiene behavior
  • 1 in 3 contact lens wearers experience a complication requiring further care

These realities of improper, unsafe contact lens practices underscore why strict enforcement of contact lens safeguards are necessary, and why Jenny Terrell, O.D., Texas Optometric Association (TOA) president, commends Attorney General Paxton's actions for defending Texans' eye health.

Adds Tommy Lucas, O.D., TOA director of advocacy: "There are very good reasons why laws exist to protect patients and consumers from the dangers of improperly used medical devices, such as contact lenses. The TOA applauds this action from the Texas attorney general's office, so that others who may cause the public harm are put on notice."

AOA continues to call for increased enforcement

Although not a regulatory enforcement entity, AOA takes seriously its central mission of serving as a resource to the public for reliable and current information related to eye and vision care, as well as safeguarding patients' eye health. That's why every October, AOA commences its '31 in 31' campaign to confront online vendors, brick-and-mortar shops and other hawkers who illegally distribute corrective, novelty or bogus contact lenses without a valid prescription.

This campaign confronts suspicious vendors and informs them of the regulatory requirements related to the sale of contact lenses within the United States. Copied to both the Federal Trade Commission (FTC) and FDA, these letters are disseminated to businesses reported to AOA's hotline, StopIllegalCLs@aoa.org.

Last year's campaign alone prompted changes at eight different companies that manifested in revised policies or wording, and visible changes to their websites.

Edward Bennett, O.D., AOA Contact Lens and Cornea Section (CLCS) chair, also commended the action of the Texas attorney general's office and the precedent it establishes pertaining to the eye health and safety of contact lens-wearing patients.

"It is evident that they recognize the importance of provider oversight as it pertains to contact lenses as medical devices as well as the need for doctors to report suspected illegal sales and adverse events," Dr. Bennett says.

"The CLCS established that email hotline for any optometrist to report a venue or online company selling contact lenses without a legal prescription as well as any patient who has been harmed as a result of receiving lenses without a valid prescription. To date, we have 34 reports of patients harmed by contact lenses they received illegally. Patient safety is the important concern of AOA and will always be."

Read more about AOA's advocacy for greater federal enforcement of contact lens provisions stipulated by the FTC's Contact Lens Rule.

See something, say something

Have information about the suspected illegal sale of contact lenses or encounter a patient harmed by illegally procured lenses? Better documentation of illegal contact lens sales helps make the case for increased enforcement at the federal level. That's why AOA requests doctors provide reports of illegal sales or complications to AOA, FTC and the FDA. Here's how:

For more information on illegal retailers or incident reporting, contact AOA's Associate Director for Coding and Regulatory Policy Kara Webb in AOA's Washington, D.C., office.

May 16, 2018

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