FDA Warns Patients to Inform Themselves About LASIK Eye Surgery Risks

In a move that has caused controversy among eye experts, the US Food and Drug Administration (FDA) has put under the lens the popular eye surgery known as LASIK (Laser-Assisted In Situ Keratomileusis).

The agency stated on its website that following patients’ input saying that they didn’t feel fully informed of the risks associated with the surgery, it released a 25-page draft guidance in July stating that a decision checklist that describes the procedure should be given to any patient considering LASIK surgery.

LASIK, which can cost several thousands of dollars and is not typically covered by insurance, is a less than 30-minute long surgery aimed at reducing a person’s dependency on eyeglasses and contact lenses by correcting vision problems like nearsightedness, farsightedness, and astigmatism.

According to the FDA info on its website, the surgical procedure uses a type of laser to permanently change the shape of the cornea – the covering of the front portion of the eye that refracts light- which, according to most eye surgeons, tremendously improves patient’s quality of life and reduces the risk of contact lens-related complications.

The FDA says in the same paper that patients should also be informed in detail about the potential side effects of the surgery which may include double vision, difficulty driving at night, seeing halos around objects, dry eyes, and, in some cases, a need for glasses as well as persistent eye pain.

Stressing the importance of people having clear and understandable information on the benefits and risks of the LASIK surgery before taking it, the draft guidelines also suggested the content that should be included on LASIK devices’ patient labeling information.

The agency also noted that when finalized, these recommendations are intended to help ensure that patients can understand information about the benefits and risks of LASIK devices that physicians should share.

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