LASIK Comments Show Divided Opinions As FDA Extends Feedback Period

The US Food and Drug Administration recently extended the comment period on a controversial draft guidance document that would recommend stronger patient safety guidelines for Laser-Assisted In-Situ Keratomileusis (LASIK) surgery, but plenty of stakeholders from all sides of the issue have already had their say.

LASIK surgery uses a laser to reshape the cornea to change the way the eye focuses, and can treat people who are nearsighted, farsighted, or astigmatic. In the 25 July guidance document, the FDA recommended a patient labeling format for LASIK devices that the agency believes would make information about the benefits and risks of LASIK treatment, including potential adverse events such as dry eye, pain, discomfort and visual symptoms, more accessible for patients and clinicians alike