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IMPORTANT SAFETY INFORMATION - CATALYS® Precision Laser System

INDICATION

The 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.

CONTRAINDICATIONS

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.

WARNINGS

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 initiate 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.

PRECAUTIONS

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.

ADVERSE EFFECTS

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, snailtrack 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.

CAUTION

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.

CATALYS® is a registered trademark, INTEGRAL GUIDANCE and LIQUID OPTICS are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. Images are owned by or licensed to Abbott Laboratories unless otherwise noted. © 2013 Abbott Medical Optics Inc.

CATALYS<sup>®</sup> Precision Laser System

The 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.

Femtosecond laser assisted cataract surgery offers a reproducible, noninvasive technique to replace the least predictable and most technically demanding steps of conventional cataract procedures.

Designed for Laser Cataract Surgery

Designed specifically for laser cataract surgery, the CATALYS® System offers:

  • LIQUID OPTICS Interface, gentle docking with minimal intraocular pressure rise and clear optics for excellent imaging and laser delivery
  • INTEGRAL GUIDANCE System - proprietary 3D Full Volume Optical Coherence Tomography (OCT) and automated surface mapping algorithms that guide laser delivery
  • Precise capsulotomies within 30µm
  • Complete segmentation and softening of the cataract with adjustable grid sizing
  • Multiple corneal incision centration options that are based on anatomical landmarks

The CATALYS® Precision Laser System combines a <600 femtosecond laser, gentle LIQUID OPTICS Interface, and integrated 3D Full Volume Optical Coherence Tomography (OCT) image-guidance system to create precise incisions in the lens and cornea. The CATALYS® System was developed in close collaboration with a medical advisory board of cataract experts from around the world. In 2012, the CATALYS® System was recognized as one of the top 100 technological innovations in the world.

Throughout the development of the CATALYS® System, numerous technology choices were made aimed at delivering excellent precision. Two of the most critical components are the patient docking interface and the image-guidance system. The LIQUID OPTICS Interface is designed to provide a stable, gentle dock and a clear optical path for the OCT and laser.

In addition, the CATALYS® System is equipped with INTEGRAL GUIDANCE System, an image-guidance system which maps ocular surfaces, establishes safety zones allowing the physician to select and customize the treatment, ensuring that the femtosecond laser pulses are delivered precisely to the intended location.

Understanding the user experience is another critical area focus for the CATALYS® System development team. The system’s intuitive and ergonomically designed user controls were developed with the needs of the patient, surgeon, technician and nurse in mind. A Medical Advisory Board of cataract experts and Medical Staff Advisory Board of dedicated technicians and nurses have had extensive input in system design and usability.

The CATALYS® System procedure consists of four steps:

The CATALYS® System includes design features that optimize the precision, safety and control of all four steps of the procedure. Two of the key features that were developed to help surgeons deliver predictability and quality of outcomes are:

LIQUID OPTICS Interface

The novel two-piece liquid interface docks the patient to the system and is designed to provide:

  • A clear optical path for real-time video, OCT imaging, and laser treatment by:
    • Filling in corneal surface irregularities with liquid
    • Creating a wide field of view, enabling all cuts to be performed in a single dock
  • A gentle dock for the patient by:
    • Minimizing the rise in intraocular pressure, which is particularly important for older cataract patients and those with glaucoma
    • Minimizing scleral contact of the interface with minimal redness of the eye after surgery

INTEGRAL GUIDANCE System

During the CATALYS® System procedure, the ocular surfaces are visualized by a proprietary, integrated Optical Coherence Tomography (OCT) system. The OCT is enhanced by sophisticated algorithms designed to ensure that the femtosecond laser pulses are delivered precisely to the intended location.

Steps in the INTEGRAL GUIDANCE System process:

  • Proprietary, 3D spectral-domain OCT imaging system visualizes the ocular surfaces
  • Algorithms process the image, automatically and accurately maps surfaces and create safety zones
  • The surgeon’s treatment plan is then customized, based on the patient’s ocular anatomy and the precise orientation of the eye
  • After the surgeon confirms the customized treatment plan, the femtosecond laser pulses are delivered precisely to the intended location, maintaining the safety zones

Videos

CATALYS® System and WhiteStar Case Video

CATALYS® System Incisions Video

CATALYS® System Workflow Video



IMPORTANT SAFETY INFORMATION - CATALYS® Precision Laser System

INDICATION

The 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.

CONTRAINDICATIONS

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.

WARNINGS

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 initiate 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.

PRECAUTIONS

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.

ADVERSE EFFECTS

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, snailtrack 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.

CAUTION

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.

CATALYS® is a registered trademark, INTEGRAL GUIDANCE and LIQUID OPTICS are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. Images are owned by or licensed to Abbott Laboratories unless otherwise noted. © 2013 Abbott Medical Optics Inc.



2013.12.20-MK8022