Report a problem (adverse event)

If you think you may have experienced a medical problem due to using Regener-Eyes, StimulEyes or any other biologic eye drop:

  • First of all, seek medical care!

  • Second, please report your experience to the FDA using the information below. With drugs made by unregulated companies, it is critical that patients and physicians report potential adverse events directly to the FDA.

Reporting by phone or email

  1. Call: 1-800-332-1088 (this is a direct phone number for Medwatch)

  2. Or send an email to: ocod@fda.hhs.gov

What’s reportable, according to the FDA?

The following information should be reported to MedWatch:

  • Unexpected side effects or adverse events

  • Product quality problems

  • Product Use/Medication Errors that can be prevented

  • Therapeutic failures

The following are FDA regulated and can be reported through MedWatch:

  • Prescription and over-the-counter medicines

  • Biologics

  • Medical devices

  • Combination products

  • Special nutritional products

  • Cosmetics

  • Food

Using Medwatch

You can use the form below to report adverse events. However, we spoke with the FDA and they encouraged us to ask you to use the email address or phone number above.

 

Is there anyone at the FDA that I can just send an email to?

Yes! ocod@fda.hhs.gov.