FDA Warns LASIK Providers about Lack of Risk Information

On December 18, the FDA sent warning letters to five LASIK providers that they are failing to provide adequate information about risks to potential patients. This targeted follow-up comes after more than three years of communication with eye care professionals about failing to give consumers adequate information to make informed decisions about laser vision correction procedures, beginning in May 2009.

Providers Targeted for Misleading Advertising

The five providers targeted in this action were:

  • 20/20 Institute Indianapolis LASIK
  • Scott Hyver Visioncare Inc.
  • Rand Eye Institute
  • Eye Center of Texas
  • Woolfson Eye Institute

At issue are the advertisements and promotional materials of the providers, which the FDA says do not provide consumers with enough information about the risks, limitations, and possible adverse events associated with the use of lasers for LASIK.

The FDA press release does not specify any particular advertisements that should include more information about risks, but seems to indicate that all advertising and promotional material needs to include information about risks.

An example of how little risk information is readily available can be seen on the providers’ websites. Of the five providers censured by the FDA, only one—20/20 Institute–includes the word “risk” on the home page of the website. The word is included in a small type disclaimer at the bottom of the page: “All medical procedures have Risks and Benefits. Results can vary from patient to patient. Risks, benefits and probability of outcome should be discussed directly with your doctor.” On none of the sites is it clear where a potential patient should look for information about risks and adverse events.

Tighter Focus for the Same Message

Over the past three years, the FDA has narrowed its focus for industry communications, but the message has remained the same.

The first two communications, in May 2009 and September 2011, were addressed to “Eye Care Professionals.” In March 2012, the FDA sent two identical letters about the lack of risk information to specific ophthalmology societies, the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology. Now the FDA has sent letters to five specific practices.

In all the communications, the message is the same: there needs to be more information about risks and adverse events. More specifically, the FDA said in its May 2009 letter, referring to its regulatory toehold on the industry: “These lasers are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.”

In its March 2012 letters, the FDA added specific risks to its communications. According to the letters, “the FDA-approved labeling for every laser approved for LASIK includes” information about the following risks:

  • Dry eye syndrome, which can be severe
  • The possible need for glasses or contact lenses after surgery
  • Potentially debilitating halos, glare, starbursts, and double vision
  • Loss of vision

The letters also make the clear statement that “FDA recommends the inclusion of this risk information in all advertising and promotional materials for FDA-approved lasers used for LASIK.”

Future Actions

The FDA has promised that if the practices do not respond adequately to this letter, it will pursue additional action, which may include:

  • Seizure of misbranded devices
  • Injunctions against the use of devices
  • Monetary fines

These actions are consistent with the FDA’s earlier statements that these actions may follow warning letters.

The FDA did not publicly specify a time frame for future enforcement actions.

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