Johnson & Johnson Vision Receives FDA Clearance for its ELITA Femtosecond Laser
New innovation designed to deliver surgeon confidence and accuracy, practice efficiency, and improved visual outcomes and recovery for patients1,2,3,4
IRVINE, CA – APRIL 27th, 2023 – Johnson & Johnson Vision*, a global leader in eye health and part of Johnson & Johnson MedTech, announced today 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 of 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)1,2,3
- Smooth stromal bed, allowing for effortless flap lifts1,3
- Industry leading laser performance with sub-micron precision3
- Exceptional ease and efficiency for practices, with an intuitive user interface, modular design, and a quick system startup in less than 5 minutes4
- Better outcomes for patients, with features designed to reduce complications, improve visual outcomes, and enable fast visual recovery.3,5
The ELITA Femtosecond Laser will be available to ophthalmologists across the U.S. later this year.
About Johnson & Johnson Vision*
At Johnson & Johnson Vision, part of Johnson & Johnson MedTech*, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of ELITA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Johnson & Johnson Vision
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ELITA FEMTOSECOND LASER
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.
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.
*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
**Xiao-Yu Song is an employee of Johnson & Johnson Vision, Inc., serving as Global Head of R&D.
1 ASCRS 2022 LASIK Flap Accuracy Comparison Between A New Femtosecond Laser and iFS, Mahipal Sachdev
2 DOF2023OTH4002: The ELITA™ Femtosecond Platform Patient Interface Design
3 DOF2023RF4002: The ELITA™ Femtosecond Laser device description
4 0155-1910 ELITA operator's manual (Flap) US edition (v0.2) REF2023RF4014
5 Sarayba, Melvin A MD*; Ignacio, Teresa S MD*†; Binder, Perry S MS, MD*‡; Tran, Dan B MD§. Comparative Study of Stromal Bed Quality by Using Mechanical, IntraLase Femtosecond Laser 15- and 30-kHz Microkeratomes. Cornea 26(4):p 446-451, May 2007