How to Report LASIK Complications to the FDA

You should report serious LASIK side effects to the FDA

Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting not allows the agency to take prompt action but also enables FDA to issue warning about a particular procedure or product.

Fortunately, when it comes to LASIK, the most frequently performed eye procedure in the world today, FDA is specifically proactive and vigilant. Therefore, reporting adverse events to the FDA is vital to better understand the safety and effectiveness of eye lasers used in LASIK surgeries and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements. This is also the main focus of the much-awaited, currently undergoing FDA's LASIK-Quality of Life study. In addition, it will also further strengthen the already established effectiveness of LASIK procedure in eye health enthusiasts.

What are some common adverse affects of LASIK?
While LASIK surgery is considered as probably the safest laser eye surgery, it is not completely free of side effects. Some of the reported adverse effects after LASIK surgery include scratchy or dry eyes, hazy vision, sensitivity to light, halos or glare, and problems seeing clearly at night. Other complications such as visual disturbances in low light are also common. While many of these effects improve over time, in some people, these are permanent. For example, in vet rare cases, creation of the corneal flap during the LASIK may permanently compromise the function of cornea.

Less typical side effects are problems with visual correction that may require a second surgery. Inflammation and infection can occur, but they are usually prevented by the use of prescription eye drops. Rarely, vision is poorer after LASIK, and permanent loss of vision has occurred.

Why report to the FDA?
You should remember that as most people or patients seeking vision correction are most concerned with elimination of glasses or contact lenses, they are actually unaware of what it means to lose visual quality. Therefore, while patient surveys typically show a high level of satisfaction with LASIK, an alarming number of satisfied patients also report complications such as visual disturbances in dim light and dry eye.

Therefore, LASIK requires more skillful surgical technique and more instrumentation than other forms of eye surgery and inaccurate and inadequate procedures during LASIK have a higher potential of complications.

How to report LASIK-related adverse events?
There are three ways of reporting any adverse or undesirable health related effect of LASIK.

Contact FDA by phone: If you had a bad experience or sustained an injury, you should file a voluntary MedWatch report at 1-800-332-1088 (1-800-FDA-1088) to the FDA and request a proper and detailed reporting form.

Contact your state medical board: Also, you could contact your state medical licensing board and file a complaint with them.

Contact your state health department or BBB: In addition, you could contact your state health department or consumer complaint organization (e.g., Better Business Bureau).

General tips on how to report a LASIK-related adverse event to FDA

There are a number of things that you should consider while reporting problems to the agency, depending on the type of problem and LASIK. The following tips will help you make your report.

  1. Report what happened as soon as possible after you discover any complication or adverse event after LASIK surgery
  2. When you contact the authority, be prepared with the following information:
    • Names, addresses, and phone numbers of people affected (If you are reporting on someone else's behalf)
    • Your name, postal and e-mail address, and phone number
    • Name, address, and phone number of doctor or hospital if where LASIK was performed
    • Details of the adverse event or a complication

If you still have any issue or concern or don't really know how to report a problem, you can also call your local FDA Consumer Complaint Coordinator.

For more detailed information on LASIK, including health risks and how to find the right LASIK surgeon, you can visit FDA's official LASIK Website.

Learn more about reporting LASIK side effects on our forums!