The FINANCIAL -- Think rinsing your eyes with hospital toilet water is revolting? In that case, what researchers found on knock-off contact lenses is sure to make you squeamish.
Published earlier this year in the Journal of Forensic Sciences, a case report from the U.S. Food & Drug Administration's (FDA's) Forensic Chemistry Center found a majority of unapproved, counterfeit and decorative contact lenses tested positive for the kinds of microbial contamination frequently found in hospital waste water or spoiled food.
Respectively, Pseudomonas aeruginosa and Bacillus cereus were just a pair of microorganisms identified in the FDA's examination of more than 300 individual contact lenses obtained without a prescription from sources such as import seizures, novelty stores, tattoo parlors, flea markets and internet marketplaces.
In fact, 60 percent (37 of 62) of the suspected counterfeit lenses and 27 percent (61 of 233) of the authentic non-corrective contact lenses obtained directly from manufacturers without a prescription were contaminated. That's compared to the 3 percent of authentic, prescribed contact lenses.
Furthermore, of the 29 different brands of counterfeit contact lenses, 48 percent had at least one sample test positive for microbial contamination. Beyond P. aeruginosa and B. cereus, other microorganisms identified are ones commonly associated with serious eye infections and even vision loss, including microbial keratitis and bacterial endophthalmitis.
Edward Bennett, O.D., AOA Contact Lens and Cornea Section (CLCS) chair and University of Missouri-St. Louis College of Optometry assistant dean, says this study is "extremely" important as it adds real-world context to other research that found increased infection risks among online-purchased contact lenses. One particular study, Stapleton (2008), found a four-times risk of microbial keratitis for patients who purchased their contact lenses online.
"We know that if the lens is contaminated and there is a break in the corneal epithelium, the risk of eye infection is very real," Dr. Bennett writes. "This study provides supporting evidence as to why this serious, vision-threating condition can occur."
Numerous reports detail infections resulting in significant vision loss in individuals using decorative or cosmetic contact lenses obtained from improper sources without medical supervision. That supervision is not only standard-of-care but also the law as eye doctors provide appropriate contact lens fitting, care instructions and follow-up care in the case of complications. Improperly fitting contact lenses can abrade the eye and open a pathway for infection, while unsafe wear and care may put bacteria directly on the eye's surface.
There are many prescription cosmetic or decorative contact lenses available through reputable providers that are safe when properly prescribed and monitored by an eye care professional.
Keeping illegal contacts at bay
Contact lenses are a safe, effective vision correction option, worn by nearly 40 million Americans. However, there is a reason that all contact lenses are classified as medical devices, requiring a valid prescription to purchase: Improper wear and care can cause significant, sight-threatening damage. The FDA's case report illustrates this concern, and further emboldens AOA's efforts to shine a light on retailers who put Americans at risk.
Throughout October, AOA is calling out online vendors, brick-and-mortar-shops and other retailers suspected of sidestepping consumers protections put in place by the Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule. This '31 in 31' campaign confronts as many vendors and informs them of the regulatory requirements related to the sale of contact lenses in the United States.
Although not a regulatory enforcement entity, the 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.
"Contact lenses are medical devices worn on living tissue; therefore, it is extremely important that they are purchased with a valid prescription," Dr. Bennett notes.