FDA Approves VisuMax Femtosecond Laser to Treat Myopia

September 22, 2016

Earlier this month, the U.S. Food and Drug Administration approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.

The VisuMax Femtosecond Laser removes a small amount of eye tissue to permanently reshape the cornea. A femtosecond (very fast, short-pulsed) laser makes cuts within the cornea, creating a disc-shaped piece of tissue that is removed by the surgeon through a small incision in the surface of the cornea. This tissue removal causes the shape of the cornea to change, which corrects the nearsightedness. A clinical study of the safety and effectiveness of the device to correct nearsightedness found the procedure resulted in stable vision correction (no contacts or glasses) in all but one of the 328 participants at six months.

Not all patients are candidates for SMILE, and individuals should carefully review the patient labeling and discuss their expectations with their eye care professional.

Click here to read the full FDA release.

Click here to learn more about the VisuMax Femtosecond Laser.

 

 



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