Johnson & Johnson Vision announced that its new ELITA Femtosecond Laser has received FDA 510(k) clearance for the creation of LASIK flaps.
ELITA will be unveiled at the 2023 American Society of Cataract and Refractive Surgery Annual Meeting in San Diego, May 5-8.
“For the last two decades, Johnson & Johnson Vision has been a leader the industry in precision, personalization and proven exceptional outcomes in laser correction,” said Xiao-Yu Song, Global Head of R&D, Johnson & Johnson Vision. “Today, we’re excited to announce that we’re building on that legacy with our ELITA Femtosecond Laser, which offers a generational leap in corneal refractive technology, with benefits for surgeons, practices and patients alike.”
The ELITA Femtosecond laser flap innovation delivers:
- Empowering surgeons with confidence, speed and accuracy, through:
- Low energy per pulse, combined with ultra-fast laser repetition rate and small spot size (1µm).
- Smooth stromal bed, allowing for effortless flap lifts.
- Industry leading laser performance with sub-micron precision.
- Exceptional ease and efficiency for practices, with an intuitive user interface, modular design, and a quick system startup in less than 5 minutes.
- Better outcomes for patients, with features designed to reduce complications, improve visual outcomes, and enable fast visual recovery.
The ELITA Femtosecond Laser will be available to ophthalmologists across the U.S. later this year.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ELITA FEMTOSECOND LASER
INTENDED USE/PURPOSE: The ELITA System is an ophthalmic femtosecond laser intended to create a corneal flap in patients undergoing LASIK surgery or other surgery treatment requiring initial lamellar resection of the cornea. The ELITA™ System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. The ELITA™ Patient Interface is designed for exclusive use with the ELITA System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused. The ELITA™ System should only be operated by, or under the direct supervision of a trained physician with certification in laser safety and in the use of the ELITA™ System for corneal flaps.
INDICATIONS FOR USE: The ELITA™ System is an ophthalmic femtosecond laser indicated in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. The ELITA Patient Interface is designed for exclusive use with the ELITA System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused.
CONTRAINDICATIONS: Lamellar resection for the creation of a corneal flap using the ELITA System is contraindicated if any of the following conditions exist. Contraindications include the following, but are not limited to: Corneal edema, Corneal lesions, Hypotony, Glaucoma, Keratoconus, Existing corneal implant, Corneal Dystrophy, Unstable Refractive error within the past year prior to treatment, Prior refractive surgery.
Undesirable Side Effects/Adverse Effects: Possible complications resulting from this surgery include the following. Potential complications are not limited to those included in this list.
Diffuse lamellar keratitis (DLK), Corneal edema, Corneal pain, Epithelial ingrowth, Epithelial defect, Infection, Corneal infiltrate/ulcer, Delayed healing, Corneal abrasion, Corneal erosion, Corneal haze, Corneal scar, Corneal scoring, Inhomogeneous stromal bed, Eye pain/excessive tearing/eye redness, Inflammation of the episclera, Iritis/Uveitis, Unexpected loss of corneal tissue, Corneal ectasia, Elevated IOP, Hemorrhage, Subconjunctival hemorrhage, Venous and arterial blockage, Retinal vascular accidents, Ocular penetration, Cataract formation, Dysphotopsia, Blurry vision or halo/starburst/glare around lights at night, Ghost/ double images, Foreign body sensation or dry eye, Ptosis, Anesthesia/drug reactions, Transient light sensitivity syndrome, Peripheral light spectrum/rainbow glare.
Vision Threatening Complications (these complications are uncommon, but possible following refractive surgery):
Perforation of the cornea, Retinal detachment, Partial or total loss of vision or eye.
Intended Patient: Adults 22 years old or older with refractive error.
NOTE: Pregnant or nursing women were not included in the clinical trials conducted.