CATALYS® Precision Laser System
CATALYS® Precision Laser System
Clinical Leadership Meets Practice Growth
The CATALYS® Precision Laser System is specifically engineered to meet your current challenges while priming your practice for the future of cataract surgery. By delivering a purpose-driven combination of outstanding clinical outcomes, immediate practice integration and a premium patient experience, it empowers you to seamlessly elevate your practice today — and seize the opportunities of tomorrow.
The CATALYS® System is designed for a high standard of clinical precision. It delivers complete capsulotomies and excellent fragmentation so you can give your patients reliably outstanding results.
- The highest demonstrated rate of complete 360˚ capsulotomies1
- Multiple centration types — including the scanned capsule for effective positioning
- Complete softening and segmentation
- High-quality fragmentation, even in dense cataracts
Highly precise, personalized incisions allow you to tailor each procedure to your patients’ unique ocular anatomy for outstanding outcomes.
- Wide, side-cut angle (anterior) range of 30 – 150˚ for anterior penetrating and intrastromal incisions
- Incredible flexibility in incision type and depth for arcuate incisions
Flexible incision options allow for more personalized and precise surgical procedures.
Anterior Penetrating Incisions
The true non-applanating LIQUID OPTICS Patient Interface does not produce corneal endothelial folds, resulting in outstanding incisions.2
The CATALYS® System’s full-volume, 3D, high-resolution optical coherence tomography (OCT) imaging and INTEGRAL GUIDANCE Technology work together to help you deliver optimal, precise treatment.
- Performs > 10,000 A-scans to capture high-resolution data for the full volume of the anterior segment
- Identifies anterior cornea, posterior cornea, iris, anterior lens and posterior lens to guide laser delivery
- Refreshes at 0.5 – 2.0 Hz for uninterrupted visualization of the eye throughout treatment
- Generates accurate pictures of the anterior chamber using 3D OCT imaging data
See how the CATALYS® System images the eye
The CATALYS® System can help you elevate your practice by driving growth through increased volume and premium conversion.
- Attract more patients to your practice3
- Convert more patients to premium procedures and IOLs3,4
- Treat more patients
“We paid for the laser within six months, which was faster than we expected to break even. Overall, cataract surgical volume is up. Access to the femtosecond laser has also somewhat shifted the balance of premium IOLs in the practice to more toric lenses.”
Dana Ondrias, HCP for Optometry Times3
The CATALYS® System is designed to fit into your practice with minimal disruption, offering an intuitive and streamlined workflow from start to finish.
- Facilitates quick, single-screen planning with a touchscreen GUI and on-screen keyboard
- Allows fast, efficient surgical planning and customization5
- Guided three-step LOI docking process automatically reduces forces on the eye during treatment
- Convenience of automated tools with adaptability and control when needed
The CATALYS® System empowers you to deliver on patient expectations by combining outstanding outcomes and a gentle, streamlined patient experience.
- Quick and gentle docking for patient comfort
- Personalized procedure from planning to incision
- Adaptive user interface for outstanding clinical outcomes
It all starts with an outstanding patient interface.
- True non-applanating design to maintain intraocular pressure
- Minimizes scleral contact, reducing post-surgery eye redness2
- Offers two patient interface sizes for the ability to dock more patients
- Not contraindicated for patients with glaucoma
|CATALYS® Precision Laser System|
LIQUID OPTICS Interface: Liquid optical immersion
12.0 mm and 14.5 mm
Intraocular Pressure Rise
Full-volume, 3D, high-resolution, streaming optical coherence tomography (OCT) imaging
Performs over 10,000 A-scans
Femtosecond diode-pumped, solid state laser engine
Touchscreen, guided user interface with on-screen keyboard
Approximate System Size6
Width: 0.87 m
Length: 1.64 m
Weight: 340 kg
1. Day AC, Gartry DS, et al. Efficacy of anterior capsulotomy creation in FLACS. JCRS. 2014;40(12):2031-2034.2. Talamo J, et al. Optical patient interface in femtosecond laser-assisted cataract surgery. JCRS. 2013; 39(4): 501-510.3. Ondrias D, Integrating laser cataract surgery. Optometry Times. March 2015.4. Aker A, Femto-cataract: Why the business model works. Ophthalmology Times, May 2015;40(8):1, 20-21.5. Friedman NJ. A comparative look at femtosecond lasers for cataract surgery, Part 1. OphthalmologyWeb, 2014.6. Operator Manual for the CATALYS® Precision Laser System. Sunnyvale, Calif.; Johnson & Johnson Surgical Vision, Inc.7. Schultz T, et al. Intraocular pressure variation during femtosecond laser-assisted cataract surgery using a fluid-filled interface. JCRS. 2013; 39:22-27
INDICATIONS & IMPORTANT SAFETY INFORMATION FOR THE CATALYS® PRECISION LASER SYSTEM
The OptiMedica® CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The CATALYS® System is contraindicated in patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal rupture, and any contraindications to cataract surgery.
Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must be completely filled with sterile buffered saline solution. If any air bubbles and/or a meniscus appear on the video image before treatment, do not initite laser treatment. Before initiating laser treatment, inspect images created from the OCT data, surface fits, and overlaid pattern in both axial and sagittal views, and review the treatment parameters on the Final Review Screen for accuracy. Safety margins for all incisions are preserved only if Custom Fit Adjustments to ocular surface(s) are applied in accordance with the instructions for use. Purposeful misuse of the Custom Fit Adjustment to ocular surfaces can result in patient injury and complication(s), and therefore must be avoided. Standard continuous curvilinear capsulorrhexis (CCC) surgical technique must be used for surgical removal of the capsulotomy disc. The use of improper capsulotomy disc removal technique may potentially cause or contribute to anterior capsule tear and/or a noncircular, irregularly shaped capsulotomy. Verify that the suction ring is correctly connected to the disposable lens component of the LIQUID OPTICS Interface during the initial patient docking procedure.
The CATALYS® System has not been adequately evaluated in patients with a cataract greater than Grade 4 (via LOCS III); therefore no conclusions regarding either the safety or effectiveness are presently available. Cataract surgery may be more difficult in patients with an axial length less than 22 mm or greater than 26 mm, and/or an anterior chamber depth less than 2.5 mm due to anatomical restrictions. Use caution when treating patients who may be taking medications such as alpha blockers (e.g. Flomax®) as these medications may be related to Intraoperative Floppy Iris Syndrome (IFIS); this condition may include poor preoperative dilation, iris billowing and prolapse, and progress intraoperative miosis. These conditions may require modification of surgical technique such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. Surgical removal of the cataract more than 30 minutes after the laser capsulotomy and laser lens fragmentation has not been clinically evaluated. The clinical effects of delaying surgical removal more than 30 minutes after laser anterior capsulotomy and laser lens fragmentation are unknown. The LIQUID OPTICS Interface is intended for single patient use only. Full-thickness corneal cuts or incisions should be performed with instruments and supplies on standby, to seal the eye in case of anterior chamber collapse or fluid leakage. Patients who will undergo full-thickness corneal incisions with the CATALYS® System should be given the same standard surgical preparation as used for patients undergoing cataract surgery for the removal of the crystalline lens. During intraocular surgery on patients who have undergone full-thickness corneal incisions with the CATALYS® System, care should be taken if an eyelid speculum is used, in order to limit pressure from the speculum onto the open eye. Patients who will be transported between the creation of a full-thickness corneal incision and the completion of intraocular surgery should have their eye covered with a sterile rigid eye shield, in order to avoid inadvertent eye injury during transport. Patients must be able to lie flat and motionless in a supine position and able to tolerate local or topical anesthesia.
Complications associated with the CATALYS® System include mild Petechiae and subconjunctival hemorrhage due to vacuum pressure of the LIQUID OPTICS Interface Suction ring. Potential complications and adverse events generally associated with the performance of capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or incision of the cornea, include: Acute corneal clouding, age-related macular degeneration, amaurosis, anterior and/or posterior capsule tear/rupture, astigmatism, capsulorrhexis notch during phacoemulsification, capsulotomy/lens fragmentation or cut/incision decentration, cells in anterior chamber, choroidal effusion or hemorrhage, conjunctival hyperemia/injection/erythema/chemosis, conjunctivitis (allergic/viral), corneal abrasion/depithelization/epithelial defect, corneal edema, cystoid macula edema, Descemet’s detachment, decentered or dislocated intraocular lens implant, diplopia, dropped or retained lens, dry eye/superficial punctate keratitis, edema, elevated intraocular pressure, endothelial decompensation, floaters, glaucoma, halo, inflammation, incomplete capsulotomy, intraoperative floppy iris syndrome, iris atrophy/extrusion, light flashes, meibomitis, ocular discomfort (e.g., pain, irritation, scratchiness, itching, foreign body sensation), ocular trauma, petechiae, photophobia, pigment changes/pigment in corneal endothelium/foveal region, pingueculitis, posterior capsule opacification, posterior capsule rupture, posterior vitreous detachment, posteriorly dislocated lens material, pupillary contraction, red blood cells in the anterior chamber (not hyphema), residual cortex, retained lens fragments, retinal detachment or hemorrhage, scar in Descemet’s membrane, shallowing or collapsing of the anterior chamber, scoring of the posterior corneal surface, snail track on endothelium, steroid rebound effect, striae in Descemet’s, subconjunctival hemorrhage, thermal injury to adjacent eye tissues, toxic anterior shock syndrome, vitreous in the anterior chamber, vitreous band or loss, wound dehiscence, wound or incision leak, zonular dehiscence.
Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.
Reference the labeling for a complete listing of Indications and Important Safety Information.