FDA MAUDE Database Reports

The FDA’s MAUDE (Manufacturer and User Facility Device Experience) database contains over 16,000 reports of LASIK-related injuries and adverse events submitted by patients, healthcare providers, and manufacturers.

Database Insights:

  • Thousands of documented complications
  • Reports include vision loss, chronic pain, and quality of life impacts
  • Many reports describe inadequate informed consent
  • Official FDA tracking of real-world adverse events

This public database reveals the true scope of LASIK complications that often go unreported in industry-funded studies.

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