The FDA has granted Johnson & Johnson Vision (JJV) 501(k) clearance for its latest laser correction technology—the ELITA Femtosecond Laser System—designed to create LASIK flaps in corneal refractive surgery.
Give me some background first.
The ELITA Femtosecond Laser System is an ophthalmic femtosecond laser designed to create a corneal flap in patients receiving LASIK / other ocular surgery that requires an initial lamellar resection of the cornea.
Further, this new laser will allow surgeons to perform refractive correction on patients with myopia, with or without astigmatism, using the SILK Procedure (Smooth Incision Lenticule Keratomileusis), a new lenticular procedure.
The system is utilized in tandem with a sterile and disposable patient interface consisting of a pre-sterilized suction ring assembly and applanation cone (for single-use and in one eye only).
What’s new with this laser?
The ELITA System is intended for patients (22+ years of age) with a refractive error.
Its new features include an ultra-fast laser repetition rate and small spot size (1 µm) combined with low energy per pulse; a smooth stromal bed (easy flap lifts); and sub-micron precision.
Anything else?
The laser also has an intuitive user interface, modular design, and a quick system startup ( <5 minutes).
The ELITA Femtosecond Laser System is indicated for patients with myopia with or without astigmatism up to -12 diopters of sphere, up to -6 diopters of cylinder, with the sum of sphere and cylinder between -1.00 and -12.00 diopters (using minus cylinder convention).
The structure is designed to reduce complications, improve visual outcomes, and enable a faster patient recovery.
When shouldn’t this be used?
According to the product’s contraindications, it shouldn’t be used in the presence of the following conditions: corneal edema, corneal lesions, hypotony, glaucoma, keratoconus, an existing corneal implant, corneal dystrophy, an unstable refractive error (within 1 year prior to treatment), and any prior refractive surgery.
How about adverse effects?
Potential complications include (but are not limited to): retinal detachment, partial or total loss of vision or eye, corneal edema, corneal pain, epithelial defect, infection, delayed healing, corneal abrasion or erosion, corneal haze, eye pain / excessive tearing or eye redness, elevated IOP, and blurry vision.
See here for the complete list.
Has it been cleared anywhere else yet?
Yes! The ELITA Femtosecond Laser System system has already received CE Mark approval in the European Union in March 2023.
When can I try it out?
According to JJV, the laser will be made available to eye care professionals across the United States later in 2023.
In the meantime, the company is planning to unveil the product at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in San Diego, May 5-8, 2023.