J&J Vision Receives CE Mark Approval for ELITA Femtosecond Laser System

Johnson & Johnson Vision has announced that they have received CE Mark approval for the ELITA Femtosecond Laser System. The laser is designed to perform refractive correction on patients with myopia, with or without astigmatism, using the SILK (Smooth Incision Lenticule Keratomileusis) procedure, a new lenticular procedure. The ELITA System utilizes an ultra-precise laser pulse and a fast laser delivery system to create a smooth corneal surface, making lenticular removal simple and easy.

“The ELITA System represents a generational leap in corneal refractive technology, leveraging advanced technologies and designs to deliver improvements in surgical experiences and patient outcomes,” Xiao-Yu Song, Global Head of R&D, Johnson & Johnson Vision, said in a company news release. “Early clinical results have shown promising visual outcomes and patient satisfaction data, leading us to believe that the ELITA System, and the SILK procedure, has the potential to elevate the standard of care for patients with myopia.”[3,4] 

The SILK procedure introduces a proprietary biconvex lenticule shape that provides several benefits, including posterior and anterior surface matching without any corneal folding when the lenticule is removed from the cornea. This shape also preserves the cornea's biomechanical strength better and leads to faster nerve regeneration due to fewer corneal fibers being cut. These advantages were documented in a source cited as [5].

The ELITA Femtosecond Laser System is suitable for myopia patients with or without astigmatism up to -12DS and up to -6DC, with a sum of sphere and cylinder between -1.00D and -12:00D using the minus cylinder convention[3]. Additionally, it can be used for LASIK flap procedures.

The system will be available soon in certain countries throughout Asia Pacific and Europe. It is important to note that the ELITA Femtosecond Laser System is not yet approved for use in the United States.

¹ DOF2023RF4002. ELITA Femtosecond Laser Device Description
² DOF2022OTH4005.
³ Manual 0155-3006
⁴ EuroTimes Supplement February 2023 | A Corneal Refractive Update on Lenticule Extraction Technology and Outcomes 5 DOF2022OTH4006 ELITA Femtosecond Platform – Biconvex Lenticule Design.