The FDA broadened its premarket approval of Carl Zeiss Meditec’s laser eye treatment to include nearsighted patients with astigmatism.
Zeiss’ VisuMax femtosecond laser was first approved by the agency in September 2016 for a procedure known as small incision lenticule extraction (SMILE) in patients age 22 and older. It has since received 510(k) clearances for use in LASIK flap surgery, keratoplasty and the insertion of corneal implants to correct vision.
The VisuMax laser creates an access incision and a lenticule inside the cornea in a single step, using one laser instead of two, through ultrashort, microscopic bursts that cut through tissue. Zeiss estimated that its trademarked SMILE treatments make up over 10% of global laser vision correction procedures.
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"The expansion of myopia treatment to patients with astigmatism will enable current and future SMILE surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” Jim Mazzo, Zeiss’ global president of ophthalmic devices, said in a statement.
The developers of the technology behind the femtosecond laser—with its pulses thousands of times faster than the electronic circuits in microchips or even measurable molecular vibrations—were recently awarded the 2018 Nobel Prize in Physics.
Gérard Mourou and Donna Strickland’s methods (PDF) of generating high-intensity ultrashort pulses through a process called chirped pulse amplification are used to cause less damage and heating of surrounding materials. The process is also used in the laser manufacture of stents.