Reporting Contact Lens Violations to the FDA and FTC

To ensure that law enforcement agencies and policymakers are aware of illegal and unsafe contact lens sales, it is important for doctors of optometry, paraoptometrists, and the public to report these sales of directly to the FTC and/or the FDA.  Please use the following links and instructions to report violations to the appropriate agencies. If you have any questions, please feel free to email StopIllegalCLS@aoa.org.

o   Federal Trade Commission (FTC)
o   FDA's MedWatch
o   FDA's online sales violations

 

FTC COMPLAINTS: To report a violation to the FTC, please follow the directions below.  You can report violations of the FCLCA, sales of contact lenses without prescriptions, non-FDA approved CLs sales, and other violations to the FTC.

1.       Go to: https://www.ftccomplaintassistant.gov/GettingStarted#crnt.
2.       Click "Other" on the bottom left of the screen.
3.       Under the "Other" menu, click "Health and Fitness," the last item.
4.       On the next page, click "Other/Not Applicable."
5.       Click the first selection, "Eyeglasses or Contact Lens."
6.       Select the options that match your complaint until completed.    

FTC: Steps: 1-3

FTC Step 4:  On the next page, click "Other/Not Applicable."

FTC Step 5: Click the first selection, "Eyeglasses or Contact Lens."



   FTC Step 6. Select the options that match your complaint until completed.

FDA COMPLAINT:
Defects, malfunctions, and contact lens related injuries/infections should be reported to FDA's MedWatch. The FDA's MedWatch Safety Information and Adverse Event Reporting Program is the initial step 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 (See below for insturctions for Medwatch Reporting). THe FDA has also provided MedWatch Learn as a web-based learning tool that teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA

1.     Visit the MedWatch webpage.
2.     Click "Report a Problem."
3.     Begin Report as "Health Practitioner" or "Consumer/Patient" by clicking the respective button
4.     Respond to questions.
5.     Review and submit data.

FDA MedWatch Step 1-2

FDA MedWatch Step 3

 

FDA Online Sales If your report is related to an online retailer that is selling contact lenses that you are concerned with, you can report the internet retailer to the FDA's "Report a Problem."

1.       Go to https://www.fda.gov/Safety/ReportaProblem/ucm059315.htm
2.       Complete the Survey
3.       Submit the form