May 2008

Did you know that you can and should tell the FDA about any complications, adverse events and other problems you experience from LASIK, LASEK, PRK, epi LASIK?

WHY FILE A REPORT:

Filing an adverse event report with the FDA, or failing to, truly does make a difference! We have learned that very powerfully this spring. We've seen all over the press the statement by the FDA that they received only 140 consumer complaints about LASIK between 1998 and 2006. That ludicrously small number is in no way indicative of the actual complications rates, which are well established in published medical literature. It is vital that we let the FDA know that there are many more of us out there so that they can take steps to improve, among other things, their warnings about laser eye surgeries for the benefit of people considering getting surgery.

WHERE TO FILE YOUR REPORT:

Just go to the following website and complete the form online:

MEDWATCH

The process is straightforward. You do NOT have to fill out every field. If you need help let us know.

WHO SHOULD FILE A REPORT:

Anyone with a poor outcome or unexpected complications. You don't have to have permanent damage or permanent side effects for your outcome to matter. Here are some examples of when we recommend that you file:

• Excessive delays to healing with poor vision and/or pain impacting significantly upon your work and other activities for an extended period
• Dry eye syndrome lasting at least six months, or for a shorter period but in a more severe form than you were given to expect
• Persistent visual distortions such as glare, haloes, starbursts, ghosting, etc
• Any intra-operative complications such as blade jams, flap problems, laser interruptions, etc.
• Any post-operative complications such as infections
• Haze and scarring
• Any other complication or side effect that has had a significant impact on your life for a significant period of time

WHAT YOU NEED FIRST

Try to get the name of the laser used in your surgery.This is almost always available on the website of the clinic you went to. If you're not sure, call the clinic and ask them to look it up in your records.

WHAT TO INCLUDE

Make sure to tell the FDA how seriously what happened to you has impacted your life, including depression or any other mental health problems.

THANK YOU FOR TAKING THE TIME TO MAKE A DIFFERENCE!