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Draft FDA Guidance Aims To Ensure Patients Understand LASIK Risks

 
• By Elizabeth Orr

The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications. 

Hand hovering over checkmarks on page reading, "Are you a candidate for LASIK?".
• Source: Shutterstock

 New draft guidance from the US Food and Drug Administration would mandate that patients considering Laser-Assisted in Situ Keratomileusis (LASIK) get additional information about potential risks of the popular vision-correcting treatment.

The agency hopes that the 28 July guidance will help ensure that patients and health care providers can access clear information about the benefits and risks of LASIK treatment, including potential adverse events such as dry eye, pain, discomfort, and visual symptoms

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