United States House Staff Learn of Dangers of Counterfeit Contact Lenses at Policy Briefing
Organized by the Health Care Alliance for Patient Safety - bringing together Congressional Staffers, FDA, industry partners, and Optometrists
(WASHINGTON) – The Healthcare Alliance for Patient Safety (APS) convened a panel of experts today on Capitol Hill to brief congressional staff in the House of Representatives on the medical dangers and safety threats posed by counterfeit contact lenses. Following a similar APS presentation for Senate staff in 2018, this panel was a critical step to ensure that Congressional staff at-large are briefed on the dangers of counterfeit lenses—especially since counterfeiting is sometimes overlooked as a major health and safety issue.
The briefing included remarks about the current statistics and dangers of counterfeit lenses in the U.S., FDA and efforts to track and mitigate counterfeit lenses, and policy solutions to prevent counterfeiting from impacting patients. Panelists represented FDA and industry, including:
- Dr. Deanna Alexander, O.D., F.A.A.O., Chairwoman, Health Care Alliance for Patient Safety
- Dr. Malvina Eydelman, Center for Device and Radiological Health, Food & Drug Administration
- Thomas Swinnen, President North America, Johnson & Johnson Vision Care, Inc
- Dr. Gary Orsborn, Vice President Global Professional & Clinical Affairs, CooperVision
- Dr. Bob Theaker, American Optometric Association representative
Staff learned that while a significant number of these dangerous, counterfeit contact lenses are sold online from suspect retailers or seized upon being imported, some make it into local novelty stores—as was reported by Popular Science Magazine.
A 2017 study conducted by the FDA which was published in the Journal of Forensic Sciences, found that 60 percent of counterfeit lenses tested came back positive for microbial contamination, which can cause medical aliments leading to vision loss.
“Ensuring patients are always using a FDA cleared or approved medical device that is authentic and prescribed by their eye care professional is critical when it comes to their eye health and safety and should be taken seriously,” said Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety. “Contact lenses are categorized by the FDA as Class II and Class III medical devices that can pose significant harm to consumers including vision impairment when proper protocols are not followed.”
APS will continue to advocate for efforts to prevent the dangerous sale of counterfeit lenses because they have serious consequences for patient health.