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CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE Phacoemulsification energy, a potential source of postoperative inflammation that can manifest as iritis, corneal edema, increased cell and flare, and hyperalgesia or pain, is reduced with LCS.5,20,21,34,39 It has been suggested that LCS may be advantageous as it may help mitigate the physiologic changes (including anterior segment inflammation as measured via laser flare photometer).34, Surgical Efficiency The LenSx Laser typically performs a surgical time under two minutes (direct suction time). China Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. Rayon / Hemp. *Glaucoma is not a contraindication when these procedures are performed using the LenSx. Chan T, et al. In this side-by-side video comparison video, Dr. Robert Weinstock highlights the evolved efficiencies of the LENSAR Laser System and the key differences between procedures performed with the LENSAR Laser versus the LenSx Laser, from patient data entry to toric IOL implantation. Femtosecond laser versus manual clear corneal incision in cataract surgery. In addition, Lensx 90 is used for number of other lens cleaning applications including microscopes, camera lenses, telescopes, IR lenses, fiber optics, and other sensitive optical components in laboratory, cleanroom, and industrial settings. This page is available in English. Purpose . For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 5. Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. VERION Digital Marker M User Manual. Lens Fragmentation France %%EOF
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* Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). applicable rules, and (3) compliance of the equipment with the applicable technical rules. 6. Cataract Surgery Indication:Cataract Surgery Contraindications: *Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface Accessory. Kohnen T, Mathys L, Petermann K, et al. 0000001520 00000 n
2. LenSx Laser System Bring proven precision and safety to every cataract procedure with the LenSx Laser, featuring ASCEND Technology the market leading femtosecond platform.1-13 Get Started Proven Precision Reproducibility and accuracy at every step.3-7 Compared to manual procedures, LenSx Laser delivers: Value in Health. Mastropasqua L, Toto L, Mastropasqua A, et al. 2020;14:1511-1519. 3yhr1-aF?3y;0ub0R a
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p<0.001, <2 minutes total time for patients under suction in cataract procedures16, As strong as manual LenSx capsulotomy integrity17, <0.1% capsular tear rate with SoftFit Patient Interface12, 13. aZ.hgRo7 FGGYfR[ 66 0 obj
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Date of Issue: February 2011. J Cataract Refract Surg. 2017.Please refer to relevant product operators manual for complete list of indications, contraindications and warnings, Check if a local MyAlcon page for your country to accesscountry product information. Retrospective chart review of 231 patients for LenSx and manual groups. Alcon equipment, Made up of tenured ophthalmic technicians 0000039391 00000 n
technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. found that an aspheric IOL that is decentered more than 0.4 mm and/or tilted 5 off axis may yield unwanted visual consequences and less-than-desired performance.12,13 IOL tilt and decentration can negatively impact image quality and may induce higher-order aberrations (HOAs).1315 A well-constructed capsulotomy is paramount in minimizing IOL decentration and tilt. That could rise more than two-fold to $744 million, provided sales . More precise, reproducible and reliable capsulotomies, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry, Less variability of anterior chamber depth with more stable post-op refraction, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags, 97.6% of corneal incisions could be opened by a blunt spatula, 99.5% of fragmentations required no additional segmentation after the laser procedure, On average, laser cataract patients spend less time in the OR, Per patient, significant time savings were observed in the following categories. 0000010600 00000 n
ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). User manual instruction guide for Alcon LenSx devices.. Alcon LenSx User Manuals Alcon LenSx, Inc. UserManual.wiki> Alcon LenSx Navigation menu Upload a User Manual Namespaces Wiki Guide Info Views User Manual Discussion / Help Navigation hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Translating several documents such as information sheets, short papers, user manuals and/or safety documents in several international languages ( English - French - German ) Documents were provided by NGO's or organizations within the UN. This platform is intended to provide general product information for education and illustration purposes. 0000000016 00000 n
SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. 2002 ES 300 Navigation system. Intraocular lens tilt and decentration measured by Scheimpflug camera following manual or femtosecond laser-created continuous circular capsulotomy. J Cataract Refract Surg. 8. Tamaoki A, Kojima T, Hasegawa A, et al. The surgeon should consider other medical options more suitable to complete the refractive treatment. It is understood that the letter of authorization must be submitted to the FCC upon request, Peru He later performed the first PRK, iLASIK, and laser refractive cataract procedures in the state. 4&a;"GCZ7p8R9TqL#E~cIaL!{6SQv77]\E uvbTZ *fb'=+(a&cn0.aw29I]YU"T,r%N^>~HWw0\+_-V&VksWYs@e
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Colombia Site for International Healthcare Professionals only. User Manual. Quick Guide Charging the Battery with the Charger Connecting to a Pc. Get ready to discover the ARGOS Biometer the smart planning solution. Models. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. Mayer et al. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. %PDF-1.5
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Indications, contraindications and description of the docking technique with personal. In this video, which contains animated simulations, youll find out what the LenSx laser looks like, how it works, and why ophthalmologist Dr. Kerry Solomon offers this technology to people looking for cataract surgery.Dr. This article is published under the Creative Commons Attribution Noncommercial License, which permits any noncommercial use, distribution, adaptation, and reproduction provided the original author(s) and source are given appropriate credit. Alcon's LenSx Laser. I certify that I am authorized to sign this application. Only properly trained personnel with experience may operate the device and control software and interpret the results. The lens of the eye must be clear in order to focus light properly onto the retina. that operates with, or is marketed with, another device that requires an equipment authorization? Laser cataract surgery, LenSx Laser, femtosecond laser technology, Several factors point to a potentially precipitous rise in the need for cataract surgery in the near future: population growth, increased awareness of and demand for excellent unaided vision, and the collateral benefits of improved vision after surgery. Is the equipment in this application a composite device subject to an Alcon, Inc. (NYSE: ACL) announced today that it has entered into a definitive agreement to acquire LenSx Lasers, Inc, a privately held company that developed the first femtosecond laser to receive U.S. Food and Drug Administration (FDA) clearance for use as a part of cataract surgery.The LenSx system is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery . VERION Digital Marker. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for 2019;19:7. Latest Offers. Equipment Class: DXX - Part 15 Low Power Communication Device Transmitter. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . *Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes). Safety Data Compared to manual techniques, using the femtosecond laser for portions of the surgical procedure may help reduce the risk of intraoperative complications. China Innovation in the surgical platform technology is ongoing. Uruguay 6 - Opaque Bubble Layer (OBL) Identifying anatomic landmarks with anterior segment imaging is a critical component of LCS to ensure proper placement of the anterior capsular opening. Designed for use in both anterior and posterior segment surgeries, the system can assist in a variety of surgical applications beyond phacoemulsification, including coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy and viscous fluid and air exchange operations. Hong Kong 0000049877 00000 n
Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR VERION Digital Marker L User Manual. ATTENTION: Refer to the ARGOS User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions. endstream
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Clin Ophthalmol. J Cataract Refract Surg. Chile addition to our existing device-specific directions for use and manuals of operation, Alconis 0000052525 00000 n
LenSx Crnea. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Pages: 34. Automobile. Select below for other countries. Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength, Descemetocele with impending corneal rupture, Presence of blood or other material in the anterior chamber, Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy, Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only), Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, Corneal thickness requirements that are beyond the range of the system, Corneal opacity that would interfere with the laser beam, Hypotony, glaucoma* or the presence of a corneal implant, Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease), Any contraindication to cataract or keratoplasty. 2022;16(2):636 DOI: https://doi.org/10.17925/USOR.2022.16.2.63, We have all heard the old adage try it before you buy it in reference to big purchases or life decisions. BUY A NEW CAR ONLINE. Vasavada et al. ISO 5-8. Alcon says the LenSx SoftFit Patient Interface delivers: I have found the OCT imaging useful in revealing lens thickness. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Request Quote. Toric Lenses with Manual Marking. Kranitz et al. 1993 ES300. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? manuals. The Patient Interface is intended for single use only. It helps us to continually improve our products. Yeu E, et al. however, the applicant remains responsible for all statements in this application. 1. Coupling of the LOI to the eye is achieved using a suction ring outside the limbus.9 LOI use also requires the precise identification of the anterior corneal surface via sophisticated imaging techniques. The swept-source OCT ARGOS Biometer with Image Guidance by Alcon is an innovative solution, designed to enhance your surgical experience and help to achieve better patient outcomes.1,2,7,8 Peru Copyright 2023 Touch Medical Media. Europe / Middle East / Africa Wed love to hear your feedback on this activity. All of the statements herein and the Ophthalmic Res. Caution: Data accurate at time of publishing, latest test results . 2016;11(3):e0152088. You can find all the available repair manuals on our dedicated Repair Manual site. J Cataract Refract Surg. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. VERION Digital Marker User Manual. 2019:1-8. Name of test firm and contact person on file with the FCC: WILLFUL FALSE STATEMENTS MADE ON THIS FORM ARE PUNISHABLE BY FINE AND IMPRISONMENT Shammas HJ. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. 0000009390 00000 n
Ophthalmic Res. 2017;67(10):1574 1579. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. The Patient Interface is intended for single use, only. Select below for other countries. Brazil Uruguay The growing body of evidence on the use of LCS is consistently showing certain advantages over manual techniques, while noting differences among the platforms.6,7,13,18,19,32,36,41 Reported complication rates are low and may be platform-related rather than category-dependent. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). A full list of approved disinfection agents can be found at www.epa.gov. 2018;13(12):e0209356. This page is available in English. Compared to VERION Reference Unit. reported on 3,355 cases operated at their facility using LenSx Laser (734 with a rigid interface and 2,621 with the SoftFit PI).18 The authors reported an overall complication rate of 0.21%, which compared favorably to the 0.31% complication rate noted in their earlier study. Lensx 90 is 100% cleanroom lens cleaning wipe & tissue. Electrified. With VERION Digital Marker LenSx (DML) integration, surgeons will be able to: The Vision Planner sends the surgical plan to the DMM, eliminating transcription errors and allowing surgeons to precisely execute their plan with image-guided precision. 9. 138 0 obj
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Offers advanced IOL power calculation with the ability to easily compare formulas and IOLs on the same page, Provides built-in optimisation algorithms to support ongoing personalisation of your SIA and A-constants, Navigate and track every step of your surgery in real time using your patients unique eye landmarks, Step-by-step procedural navigation using CENTURION. at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced 0000001076 00000 n
The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. Argentina . Russia, Asia Pacific AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. 0000093732 00000 n
Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. additional equipment authorization? 2016;1(1):1-4. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 2017;43:15711574. B|a:BbN`a8dxC/tN&UF./2-3;?
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The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. For relevant training content from industry thought leaders, LenSx Laser Important Product Information. Mexico ZEISS IOLMaster 700 510k Submission 2015. Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. trailer
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Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. View the latest owner's manuals for your car. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. reported posterior capsule rupture in two of 45 (4.4%) eyes with posterior polar cataracts;27 previous studies using manual hydrodelineation reported posterior capsule rupture as high as 26 to 36% in these types of cases.2731, Outcomes It is made from 70% rayon and 30% cellulose. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. 1.5x faster scanning speed than IOLMaster* 700, Angle-to-angle, cornea-to-retina OCT imaging provides real-time guidance for capturing accurate measurements, Integrated Alcon Vision Planner with automated and convenient planning software offers sophisticated astigmatic management tools, including an LRI nomogram, One-touch software and remote planning options, Outperformed IOLMaster* 700 by 41% in grade 4+ cataracts, OCT-enhanced keratometry shown to rival Lenstar, Uses segmented axial length, improving refractive prediction error, which may lead to better IOL selection, Provides intra-operative guidance with digital overlays throughout LenSx, Provides image registration and real time eye tracking to compensate for cyclotorsion. 7. John Davidson, MD, is a paid consultant to Alcon. Alcon LenSx User Manuals User manual instruction guides for Alcon LenSx devices. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. 2016;42:50-61. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. May 2019. hb```c``YRAbl,`@: Alcon Laboratories, Inc. 6201 South Freeway Distrubuted By: Fort Worth, TX 76134-2099 USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK. will continue to comply with the FCC's technical requirements. : Does short-term confidentiality apply to this application? Shammas HJ, Ortiz S, Shammas MC, et al. hb``a``x
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Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. Arcuate Corneal Incisions The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. specified in this application, (2) compliance statement labeling pursuant to the 91 0 obj
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