Abstract
Contact lenses, when worn and cared for properly, are a safe and effective form of vision correction used by an estimated 45 million Americans. However, contact lens wearers are at risk for contact lens–related eye infections, especially when wearers do not practice proper contact lens wear and care habits. These infections, affecting the cornea and known as microbial keratitis (Figure), can lead to serious adverse health outcomes. Because contact lenses are regulated by the Food and Drug Administration (FDA) as medical devices, contact lens–related corneal infections should be reported to FDA as an adverse event. To illustrate their serious health implications, six cases of contact lens–related corneal infection, in which sleeping in lenses was reported as the main risk factor, are presented. Consequences of infection reported among the identified cases included the need for frequent administration of antibiotic eye drops, multiple follow-up medical appointments, and permanent eye damage. Health education measures directed toward contact lens wearers should emphasize raising awareness of the risks of sleeping in contact lenses as well as adherence to all recommendations for the wear and care of contact lenses. Additional measures are needed to educate eye care professionals about the need to report contact lens–related corneal infections to MedWatch, the FDA Safety Information and Adverse Event Reporting program (https://www.fda.gov/MedWatch/).
Highlights
Using the data accumulated in the adverse event reporting program, contact lens stakeholders can work together to determine what improvements can be made to contact lenses, care products, manufacturer guidelines, and labeling
The Contact Lens Institute had no involvement in the drafting or review of this report
Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2015
Summary
Corneal Infections Associated with Sleeping in Contact Lenses — Six Cases, United States, 2016–2018. Because contact lenses are regulated by the Food and Drug Administration (FDA) as medical devices, contact lens–related corneal infections should be reported to FDA as an adverse event To illustrate their serious health implications, six cases of contact lens–related corneal infection, in which sleeping in lenses was reported as the main risk factor, are presented. Outside of MedWatch, no formal surveillance for contact lens–related corneal infections exists in the United States; in 2010, an estimated 1 million outpatient and emergency department visits were reported for keratitis of all types [1]. In collaboration with the Eye and Contact Lens Association (formerly known as the Contact Lens Association of Ophthalmologists), six cases of contact lens–related corneal infections were identified that were diagnosed in the last 2 years in which sleeping in lenses was reported as a risk factor.
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