FDA Approves Use of Femtosecond Laser, VisuMax, for Myopia Operations

December 11, 2017

The U.S. Food and Drug Administration (FDA) approved today the use of the VisuMax femtosecond laser for small incision lenticular extraction, also known as SMILE. This procedure can reduce or eliminate myopia in patients who are at least 22 years old.

It is important to note that not all patients are candidates for SMILE, so they must be carefully examined to determine whether they meet the requirements of the surgery. Also, patients should discuss the expectations of the operation with an ophthalmologist.

"This approval expands the number of options of surgical treatments to correct myopia," said Dr. Malvina Eydelman, director of the division of ophthalmology and otolaryngology apparatuses at the Radiological Health and Device Center.
Myopia is a common condition in which nearby objects are seen clearly and distant objects are blurred. This occurs when the eye focuses the light in front of the retina because the cornea is too curved or the eyeball is too long.

Thanks to the femtosecond VisuMax laser's short pulses and speed, it removes a small amount of ocular tissue to permanently modify the shape of the cornea through cuts that are made inside the cornea. These cuts result in a disc-shaped piece of ocular tissue, which is removed by the surgeon through a small incision on the surface of the cornea. By removing this tissue, the shape of the cornea changes, which can correct myopia.

A clinical study of the performance and safety of this device for correcting myopia found that the procedure corrected vision in six months: of the 328 participants evaluated in six months, all but one had 20/40 vision or better without the help of frames or contact lenses.

The most common complications during the procedure include difficulty when removing the corneal tissue and the loss of suction that keeps the laser aligned with the eye. On the other hand, some of the complications that may occur after surgery include the presence of residues in the area where tissue was removed, dry eye, flashes, and moderate or severe halos.

The femtosecond VisuMax laser is manufactured by the Carl Zeiss Meditech Corporation in Dublin, California.

The main objective of FDA is to guarantee the protection, effectiveness, and safety of human and veterinary drugs and vaccines, other biological products for human consumption, as well as of medical devices. This agency is also responsible for food safety, cosmetics, dietary supplements, products that generate electronic radiation, and tobacco products.

Source U.S Food & Drug Administration