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FDA Warns LASIK Providers: Stop Making False Claims

The U.S. Food and Drug Administration is cracking down on eye doctors who make false safety claims and promises about the popular LASIK eye surgery.

The FDA’s latest letter follows an earlier warning from May 2009. It is giving eye doctors 90 days to update any advertising or promotional materials that make false claims about the popular surgery. After that, the agency will take regulatory action. Agency actions may include warning letters, product seizures, injunctions and civil money penalty proceedings.

"It's about the false claims and not adequately providing consumers with information about the risks associated with the procedure," said FDA spokeswoman Erica Jefferson in an news release.

LASIK, a laser cornea-shaping procedure, does come with risks. Those risks are small but can include vision loss, under- or over-correction of vision, dry eye, infection, glare, halos and or double vision.

And LASIK isn't for everyone. At this point in time, the procedure can help repair vision among people who are nearsighted, farsighted or have an astigmatism (irregular curvature of the cornea), all conditions known as refractive errors.

In determining whether labeling or advertising is misleading, the FDA considers, among other factors, whether the labeling or advertising omits important information related to the device’s limitations and risks.

It is critical to disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the devices’ use. Advertisements and promotional materials that do not include appropriate risk information may be misleading.

Any person, including an eye care professional, who misbrands a restricted device through false or misleading advertising, or by causing the device’s labeling to be false or misleading, violates the FD&C Act and is subject to enforcement action.

The FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health.

According to the FDA, these are the risks and limitations of the LASIK surgery:

• Over-treatment or under-treatment - are you willing and able to have more than one surgery to get the desired result?
• May still need reading glasses - do you have presbyopia?
• Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
• May permanently lose vision - do you know some patients may lose some vision or experience blindness?
• Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
• Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
• Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
• Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
• Patient information - have you read the patient information booklet about the laser being used for your procedure?

The FDA offers this guide to finding the right LASIK doctor:

• Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
• Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
• Informative - is your doctor willing to spend the time to answer all your questions?
• Long-term care - does your doctor encourage follow-up and management of you as a patient? Your preop and postop care may be provided by a doctor other than the surgeon.
• Be comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?

The FDA’s website contains a list of all FDA-approved lasers for refractive procedures, including lasers approved for LASIK. This site also provides information about the scope of the intended uses of each FDA-approved laser and the associated risks. Risk information may include side effects, warnings, precautions, and contraindications.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.




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