Harmed by contact lenses? Report now

January 14, 2016
Reporting of adverse events to FDA helps ensure patient and public safety.

Doctors of optometry play a crucial role in bolstering AOA efforts to protect public health and allow for safe contact lens use by patients—and it all begins with your attentive, professional awareness and a few simple keystrokes.

Contact lenses, whether corrective or plano, are classified as medical devices by the U.S. Food and Drug Administration (FDA), and require a valid prescription under federal law to purchase.

Improperly used contact lenses can lead to corneal abrasions, corneal edema, corneal ulcers or eye infections, necessitating medical or surgical treatment, ultimately increasing costs and undermining quality of life. That's where doctors make an immediate difference, particularly when the contact lenses were obtained illegally (without a prescription or without abiding by the Fairness to Contact Lens Consumers Act [FCLCA]).

By formally reporting "adverse events" to the FDA, doctors offer critical data that not only spurs federal officials to take action, but also provides AOA key data with which to advocate for members and their patients. Better documentation on adverse events associated with contact lenses will foster more effective oversight by the FDA—which has authority over the marketing of medical devices, such as contact lenses.

How to report adverse events associated with contact lenses

The FDA's MedWatch Safety Information and Adverse Event Reporting Program is that first, and most crucial, step for doctors to take when reporting adverse events. Information may be reported to MedWatch by phone at 800.FDA.1088; by fax at 800.FDA.0178; by mail to 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or online by following these quick and easy steps:

  1. Visit the MedWatch webpage.
  2. Click 'Report a Problem.'
  3. Click 'Begin Report as Health Practitioner.'
  4. Populate the report categories.
  5. Review and submit data.

What if doctors aren't reporting an adverse event, but still have information about a suspected illegal sale of corrective or novelty plano contact lenses? Better documentation on illegal contact lens sales also helps make the case for the U.S. Federal Trade Commission (FTC)—which has jurisdiction over the retail sales of contact lenses under the FCLCA—to step up enforcement.

AOA asks doctors to provide reports of illegal sales to the AOA Washington office, to then submit to the FTC.  Here are three additional links where doctors can alert federal authorities to suspected illegal sales of contact lenses.

Find additional instructions for completing Form FDA 3500, the voluntary adverse event reporting form for health care professionals.

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