FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices

The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.

The authors provide content and formatting information for patient labeling information due to concerns that some patients are not getting and/or understanding information regarding the dangers and benefits of LASIK devices. The labeling suggestions are meant to improve the doctor-patient conversation about the advantages and disadvantages of LASIK.

In the paper, it is stated that a description of the eye and the procedure, as well as an explanation of what LASIK is and what the laser performs, should be included in the preferred format and content of patient labeling.

Additionally, a description of patient risks should be included together with the indications for usage, benefits, alternatives, contraindications, warnings, and precautions.

The labeling should also include information about relevant clinical studies, a description of what to expect before, during, and after surgery, as well as details regarding the LASIK equipment that will be utilized in the process.

"The FDA recommends that a copy of the patient decision checklist be provided to the patient so that the patient can refer back to this important information," the authors write. "The FDA also encourages device manufacturers to develop a plan to ensure that patients are adequately informed of the risks of LASIK."