Government updates LASIK program

Article Outline

 

The U.S. Food and Drug Administration (FDA) has stepped up its efforts to ensure that patients and eye care practitioners receive accurate information regarding laser refractive correction. The new measures were outlined in a May 22, 2009, FDA Letter to Eye Care Professionals (see Box 1). They are based on the recommendations of a public advisory panel, convened by the FDA on April 25, 2008, to consider patient input regarding their experiences with LASIK. In response to input from the public and LASIK experts during the panel meeting, the FDA has updated materials, Web services, and some LASIK-related standards. A summary of the measures follows.


•FDA LASIK Web site

o.The FDA has made it easier for LASIK patients to report problems within 2 clicks from the FDA LASIK Web site: On the LASIK home page (www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK), select “Report a Problem” at the bottom of the left column, then select “Report a LASIK Problem to MedWatch.”


o.The FDA has updated the “Other Resources” section of the Web site to provide a wider range of information about LASIK to patients and physicians.


o.The FDA has clarified the Web site's “Contact Us” section to make it easier to submit a question about LASIK to the agency or submit a comment or concern about LASIK for the public record.




•SightNet

o.The FDA has updated the LASIK-related information in SightNet, the program used by health care professionals at participating facilities, to share concerns about potential safety issues with ophthalmic medical devices, and report problems to the FDA. The program now emphasizes that halos, glare, night vision problems, and dry eye from LASIK should be reported to the FDA.




•Patient Information Card

o.The agency has developed a card for physicians to fill out with the patient's eye measurements before LASIK surgery. Patients can keep this card to help their doctor calculate the lens implant power should they need to have future cataract surgery. The card can be downloaded at www.geteyesmart.org/eyesmart/upload/kcard.pdf.




•FDA Recognition of ANSI Laser Systems for Corneal Reshaping

o.In March 2009, the FDA officially recognized a new LASIK standard from the American National Standards Institute (ANSI), titled “Laser Systems for Corneal Reshaping.” The FDA, as a member of ANSI, works closely with this and other national and international standards groups. This group meets to develop consensus on appropriate national and international standards for device testing and performance.




•LASIK Docket

o.The FDA has opened a public docket for LASIK so that any interested person can post comments or concerns regarding LASIK. This docket is Web-based, and all comments submitted can be viewed by the public. All comments on the docket are examined and assessed by FDA staff on a regular basis. Interested parties can submit comments about LASIK experiences for the public record at “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket” by selecting the icon next to “Add Comments.” (Personal identification information should not be included, because the record is open for public view.) Comments can be viewed at www.regulations.gov with a keyword, (e.g., LASIK) or by typing in the LASIK docket number, FDA-2008-N-0488.




•FDA Letter to Eye Care Professionals

o.The FDA Center for Devices and Radiological Health has issued a letter to eye care professionals (see Box 1) providing them with important information about the promotion and advertising of FDA-approved lasers used during LASIK. This letter was sent to the American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, American Optometric Association, and the Optometric Council on Refractive Technology to help the FDA disseminate this important information to their members.




Box 1.

FDA Letter to Eye Care Professionals

The following is the text of a May 22, 2009, Letter to Eye Care Professionals from the U.S. Food and Drug Administration Center for Devices and Radiological Health outlining agency concerns over the marketing of laser vision correction and efforts the agency hopes eye care practitioners will take to ensure patients are properly counseled regarding the procedure. The letter was issued by Timothy A. Ulatowski, the Director of the center's Office of Compliance.

The Food and Drug Administration (FDA) is writing to provide you with important information about the promotion and advertising of FDA-approved lasers that are used during laser-assisted in-situ keratomileusis (LASIK) procedures and to let you know where you may get additional information, if needed.

On April 25, 2008, FDA's Ophthalmic Devices Panel held a public meeting to discuss issues concerning post-market experiences with LASIK procedures. Both at the meeting and through submissions to a subsequently established public docket, the FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA has received complaints that eye care professionals' advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures.

The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health.

The FDA has approved several lasers intended for use in LASIK procedures. A list of all FDA-approved lasers for LASIK procedures may be accessed through the FDA's Devices@FDA service (www.accessdata.fda.gov/scrIpts/cdrh/devicesatfda/index.cfm).

This Web page also provides information about the scope of the intended uses for each FDA-approved, restricted device and the risks associated with the use of the device. The information about risks may include warnings, precautions, side effects, and contraindications.

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.

A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 U.S.C. 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 U.S.C. 321(n)).

Further information about LASIK procedures and FDA's current LASIK activities can be found on the FDA LASIK Web site.

If you become aware of an advertisement for any of these restricted devices that may be in violation of the Act, please forward it to FDA's Center for Devices and Radiological Health (CDRH), Office of Compliance at the address listed above. Questions concerning this letter may be directed to Ann Simoneau, Regulatory Counsel, CDRH, Office of Compliance at (301) 796-5514.

“These are just a few of the ways the FDA is working to ensure that patients and physicians have current, accurate information to help them with their decisions about LASIK and to facilitate their reporting problems. As we continue to monitor the safety and effectiveness of LASIK we will also explore additional ways that we can improve the quality of information available to the public about LASIK and ways to ensure that the FDA receives better information about problems with LASIK,” the agency Web site notes.