Contact Lens-Related Corneal Infections - United States, 2005-2015.

Keratitis (inflammation of the cornea) can result from contact lens wear or other causes. Keratitis from all causes, including contact lens wear, results in approximately 1 million clinic and emergency department visits annually, with an estimated cost of $175 million in direct health care expenditures in 2010 (1). Approximately 41 million U.S. residents wear contact lenses, and in 2014, >99% of contact lens wearers surveyed reported at least one behavior that puts them at risk for a contact lens-related eye infection (2). The Center for Devices and Radiological Health at the Food and Drug Administration (FDA) regulates contact lenses as medical devices, and certain adverse events related to contact lenses are reported to FDA's Medical Device Report (MDR) database. To describe contact lens-related corneal infections reported to the FDA, 1,075 contact lens-related MDRs containing the terms "ulcer" or "keratitis" reported to FDA during 2005-2015 were analyzed. Among these 1,075 reports, 925 (86.0%) were reported by a contact lens manufacturer and 150 (14.0%) by an eye care provider or patient. Overall, 213 (19.8%) reports described a patient who had a central corneal scar, had a decrease in visual acuity, or required a corneal transplant following the event. Among the reports, 270 (25.1%) described modifiable factors known to be associated with an increased risk for contact lens-related corneal infections, including sleeping in contact lenses or poor contact lens hygiene; the remainder did not provide details that permitted determination of associated factors. Continued efforts to educate contact lens wearers about prevention of contact lens-related eye infections are needed.

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.

Medical devices are often overlooked as a contributor to adverse events. In clinical practice, physicians are aware of the potential for adverse effects from drug products, which are routinely included in differential diagnoses of patients' presenting complaints. However, physicians may not always consider that the use, misuse or malfunction of a medical device, and/or its components, may result in a patient's presenting signs and symptoms or lack of improvement. Consideration of medical devices is particularly important in the pediatric population, who may be especially susceptible to device-related adverse events due to their smaller body size, weight and ongoing rapid growth and development.