David W. Parke, II, MD
Executive Vice President and CEO
American Academy of Ophthalmology
P.O. Box 7424
San Francisco, CA 94120-7424
Dear Dr. Parke:
We are writing to follow up on our conversation from last fall and to provide information that members of your organization have requested about the risk information that should be included in eye care professionals’ advertisements and promotional materials for FDA‑approved lasers used in laser-assisted in-situ keratomileusis (LASIK).
On September 23, 2011, the Food and Drug Administration (FDA) issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures, including LASIK. The letter is available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm272960.htm.
In this letter, FDA emphasized the importance of providing adequate risk information in the advertising and promotion of FDA-approved lasers used in refractive procedures and directed eye care professionals to additional relevant information. This letter followed a May 22, 2009, letter issued in response to information received by FDA that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures. As explained in these letters, lasers used in refractive procedures are restricted devices and are misbranded under the Federal Food, Drug, and Cosmetic Act if their labeling or advertising is false or misleading (21 U.S.C. §§ 352(a), 352(q), 360e(d)(1)(B)(ii), and 360j(e)). 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 (21 U.S.C. § 321(n)).
Whether a particular advertisement or promotion is false or misleading is determined on a case-by-case basis and, in making this determination, FDA considers many factors, including how risk information is described, displayed, and located. However, the FDA‑approved labeling for every laser approved for LASIK includes the risks of dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision. FDA recommends the inclusion of this risk information in all advertising and promotional materials for FDA‑approved lasers used for LASIK. In addition to this common risk information, advertisements and promotional materials should include the contraindications for the particular laser that the eye care professional uses. The contraindications for each laser can be found in the approved labeling for the laser. Moreover, eye care professionals should consider other risk information, such as warnings and precautions, in the approved labeling for the laser used by the professional to determine whether that risk information should be included in their advertisements and promotional materials. The approved labeling for each of the lasers approved for LASIK can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192109.htm. The approved labeling for lasers approved for PRK and other refractive surgeries can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192110.htm.
FDA also has available on its website general background and risk information that may be helpful when developing advertisements and promotional materials concerning FDA‑approved lasers used in refractive procedures. That information can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm. In particular, information on the most common risks, including those mentioned above, associated with refractive lasers intended for LASIK procedures is available at FDA’s LASIK website at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061354.htm.
Office of Compliance
Center for Devices and Radiological Health