VERION Reference Unit User Manual, Part I. AutoStainerXL. 2019;60(11):1043-1049. Please refer to the VERION Digital Marker User Manual and LenSx Laser Operator's Manual for a complete list of indications, contraindications and warnings. Value in Health. Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` 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 stay up-to-date with equipment certification Tab M8 Quick Start Guide. It should also be noted that in four of these cases, IOL implantation was still achievable: and two in which sulcus IOL implantation was safely performed in eyes in which the tear extended to the posterior capsule; and two in which in-the-bag implantation was successfully performed in eyes in which the tear extended to the equator without posterior capsule involvement or vitreous loss. 14. y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. endstream endobj 46 0 obj <>stream IOL alignment with the visual axis is important to achieve the targeted refractive outcome. publication. VERION Digital Marker User Manual. 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. To evaluate the safety, efficacy, and predictability of implantable collamer lens (ICL) implantation combined with a LenSx femtosecond laser-assisted limbal relaxing incision (LRI) for the correction of corneal astigmatism. 64 0 obj <> endobj xref applicable rules, and (3) compliance of the equipment with the applicable technical rules. q7WRz#]2vn^-,\_+D\qH~.Qo_ 2017. 0000002723 00000 n 2017;43:15711574. 2017;43:348-352. 0000000016 00000 n Posted: 12/18/2018. J Cataract Refract Surg. * Trademarks are the property of their respective owners. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. Chen X, et al. Alcon recommends using Isopropyl as disinfectant. at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced User Manual. Select below for other countries. Reproducibility and accuracy at every step. Reduction of ultrasound energy has been associated with a reduced risk for lens capsule complications and corneal endothelial injury.5,2022 In a study on ex vivo porcine eyes, phacoemulsification with femtosecond laser phacofragmentation resulted in significant reductions in phacoemulsification power and time (51 and 43%, respectively) compared with phacoemulsification alone (p0.001 for both comparisons).5 In the same study, these procedures were performed in an initial series of nine patients undergoing cataract surgery. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). (U.S. CODE, TITLE 47, SECTION 503). Roberts et al. Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. 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. Br J Ophthalmol. J Cataract Refract Surg. Hong Kong Peru VERION Reference Unit User Manual Part II. 0000010600 00000 n Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? 2018;13(12):e0209356. It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. Future Directions Select below for other countries. These letters are chosen by the applicant. 2017;43:486491. The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. ^>{.4Ke- Document Type. E: doctorjohn@johndavidsonmd.com. 2017;67(10):1574 1579. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Smart Clock 2 Manual. J Refract Surg. J Cataract Refract Surg. Singapore, More precise, reproducible and reliable capsulotomies3-5, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry6, Less variability of anterior chamber depth with more stable post-op refraction7, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags7*, 97.6% of corneal incisions could be opened by a blunt spatula7*, 99.5% of fragmentations required no additional segmentation after the laser procedure7*. used electron microscopy to analyze the edge characteristics of capsulorhexes cut with manual techniques compared with capsulotomies performed with two generations of the LenSx Laser platform (LenSx Laser pre-SoftFitTM PI version 2.16 and LenSx Laser post-SoftFitTM PI version 2.20), two generations of the Victus* platform (Victus I version 2.5 and Victus II version 2.7SP2), and Catalys* (version 2.15.13). 0000018265 00000 n The Patient Interface is intended for single use, only. manuals. She is a consultant to and speaker for Alcon. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. 2016;10:20212029. 5 - Manejo de las complicaciones. J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Solomon has been ranked among the top 1% of ophthalmologists in the United States (U.S. News \u0026 World Report). Select below for other countries. have been made with the manufacturer to ensure that production units of this equipment . hb``a``x 01G3020b^,Tp73\)0_Mp/7CaD that operates with, or is marketed with, another device that requires an equipment authorization? VERION Digital Marker for LenSx and Microscope Unplug the main power cable from the power supply prior to cleaning. endstream endobj 139 0 obj <. LenSx Laser Operator's Manual. At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. endstream endobj 45 0 obj <>stream Singapore. An Y, Kim H, Joo C-K. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 0000010625 00000 n 0000013979 00000 n Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. ARGOS Biometer User Manual. 2019. * Retrospective chart review of 225 patients for LenSx and manual groups. The inclusion criteria were: 1) patients with age-related cataract or complicated cataract; 2) > 18 years of age; 3) planned to receive LenSx laser-assisted cataract surgery and phacoemulsification in at least one eye; and 4) written informed consent was provided by the patient prior to enrolment in the registry. Factors that influence the measurement of patients eyes are listed in the User Manual (Table 1): pseudophakic eye, wearing contact lenses, fixation problem, cornea opacity, non-intact cornea, refractive surgery, blood in the vitreous humor, retinal detachment, keratoconus, asteroid hyalosis, ambient light in the room, and deformation of the corneal shape. Copyright 2023 Touch Medical Media. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. Rayon / Hemp. Brazil 0000052525 00000 n Mayer et al. 0000039391 00000 n Pages: 22. Quick Guide Charging the Battery with the Charger Connecting to a Pc. hbbd```b``"'@$=da1`v3I`eq +XVDJ8m"`qM)sA o> W`Jg`: J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. This platform is intended to provide general product information for education and illustration purposes. 0000016974 00000 n 6. Ali MH, et al. Zhang X, et al. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. France 2016;100:1201-1205. A cadaver eye study showed that cataract incisions made with a femtosecond laser were reproducible and stable, and were less likely to leak or become deformed during intraoperative maneuvers as compared to manual incisions.11 Mastropasqua et al. 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa V|{OiFM#;cRImrUZ}"P. &GCt"rH!kjAlO (`Bj`fHu*])5ED1*{jW1jr2/9*pv_NZ$wQDue_6 x2 0000001520 00000 n The surgeon should consider other medical options more suitable to complete the refractive treatment. CONTRAINDICATIONSCataract Surgery Contraindications 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) History of lens or zonular instability Any contraindication to cataract or keratoplasty This device is not intended for use in pediatric surgery. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR The ARGOS Biometer is faster than other market-leading biometers.1-5 With a biometric data capture time of less than1second and a higher scanning speed, 50% faster than IOLMaster* 700, the ARGOS Biometer allows for enhanced efficiency and accuracy of eye measurements.1,9. 3. Show all Leica Laboratory Equipment manuals. 2017. Electrified. Nikon Micro-Nikkor Camera Lens User Manual. for possession or distribution of a controlled substance. Akman A, Asena L, Gngr SG. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? Spain Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. MOVU ARGOS 510(k) Summary 2019. Optical Radiation - This device is equipped with a Class 1 laser light source. Nagy Z. CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Its content should not be considered medical advice, diagnosis or treatment recommendations. Is the equipment in this application a composite device subject to an 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: Chile User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. reported significantly worse corrected distance visual acuity at one month in eyes operated with manual versus laser techniques, which they attributed to the possible inducement of higher-order aberrations secondary to lens tilt in the manual group that could not be corrected with spectacles.13 The authors noted that IOL decentration correlated with changes in manifest refraction at one month and one year after surgery and that capsulotomies created with the LenSx Laser yielded a more stable refractive outcome. Poor architecture of the main clear corneal incision (CCI) is a primary factor leading to surgically induced astigmatism (SIA), which can have consequences for post-surgical vision.10 The importance of such consequences may be magnified when implanting a multifocal or toric IOL. Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. Laser cataract surgery (LCS) offers several surgical advantages over manual cataract surgery: the laser fragments the lens and creates corneal incisions and capsulotomies with a level of precision, control and reproducibility unachievable with manual techniques. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. The LenSx Laser offers the benefit of a gurney rather than a fixed bed. 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. (NOTE: This text will appear below the equipment class on the grant): EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for LENSX LASER SYSTEM OPERATOR'S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 Date of Issue: January 2011 Alcon Laboratories, Inc. Distrubuted By: 6201 South Freeway Fort Worth, TX 761342099 Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK DRAFT 0086 fLENSX LASER SYSTEM OPERATOR'S Europe / Middle East / Africa Ophthalmic Res. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. hbbd```b`` This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. The user manual is designed to give you all the inside tips, instructions and general information you need to get the best performance out of your product. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. LenSx Laser Important Product Information. Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. 2019. At the end of the case, the DMM sends surgical data back to the Vision Planner14: An image of the final IOL position at the end of the case can be captured and stored for future reference.12, Dynamic overlays can help to precisely execute incisions14, Image-guided integration can help to achieve greater capsulorhexis accuracy15, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks14, An image of the final IOL position is captured and stored for future reference12, Disclaimer: (1) These images are for illustrative purposes only and may not reflect the current product and (2) The patient information is hypothetical and not based on real patient data, For relevant training content from industry thought leaders. 13. 0000058734 00000 n 4. * Requires VERION Digital Marker L (with LenSx). ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). Only properly trained personnel with experience may operate the device and control software and interpret the results. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients, Comparing the new SS-OCT biometer ARGOS (OCTB1), which uses individual refractive indices to measure axial length, with the IOLMaster 700 (OCTB2) and OA-2000 (OLCR), which use equivalent refractive index, Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer, Evaluating the repeatability and reproducibility of the measurements obtained with the ARGOS and to compare them with the results obtained with the IOLMaster 500, An Y, Kim H, Joo C-K. 0 Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. View the latest owner's manuals for your car. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. Show Description +. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. ZEISS IOLMaster 700 510k Submission 2015. J Refract Surg. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. Rayon / Hemp. 2015;41(5):1109-1110. The Patient Interface is intended for single use only. Paper presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. 0000039322 00000 n HWn0}gvK$ 4!x`mH8{$xK"3&F\92MAOod!MN'i)M~.UyI3.4Y4,8>Nx+^`^1 H93N`RCeW+B Sl,xPLpg1!||vB#r|2&=6vX { [hqeA Arcuate Corneal Incisions Tamaoki A, Kojima T, Hasegawa A, et al. As product information, availability, indication and trade names may vary from country to country, the content of this site may not be fully in line with the approved or cleared product information in the country you are accessing from. Alcon's LenSx Laser. noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. reported a 1.9% anterior capsule tear rate when using the Catalys*, which was higher than manual.36, Published reports also indicate LCS use contributes to a reduction in complications during training cases by both residents and fellows.37 Reductions in total ultrasound, phacoemulsification, torsional, and aspiration times compared with manual techniques may be particularly important in this setting, as training surgeon cases have historically been associated with high complication rates.37 In published studies, risk of inducing an anterior capsule tear has been most closely associated with lack of surgeon experience, evidenced by lower rates among more experienced surgeons.38, Postoperative Inflammation Singapore. Application for Equipment Authorization FCC Form 731 TCB Version. This page is available in English. 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. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Cathleen McCabe, MD, moderator LenSx user for 4 years Cathleen McCabe, MD, is a cataract and refractive specialist practicing at The Eye Associates of Bradenton and Sarasota, Florida. %%EOF 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. VERION Reference Unit User Manual Part I. 0000058697 00000 n 80-0001. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. Latest Offers. J Cataract Refract Surg. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. Cleanroom wipes, Lensx 90. "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . <2 minutes total time for patients under suction in cataract procedures, Superior endothelial cell retention at 1 and 3 months, Improved central corneal thickness at Day 1 for quieter eyes, Faster rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage, * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx, In a retrospective chart review, a greater proportion of eyes treated with LenSx, * Retrospective chart review of 225 patients for LenSx, Complete efficiency, precision, and confidence in the anterior segment. Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. Show all featured manuals. Cataract surgery benefits patients beyond improved vision, including a decrease in falls and improvements in general physical, cognitive, and emotional wellbeing.3, In the US, femtosecond laser technology during cataract surgery is approved to create corneal incisions, perform the capsulotomy, and fragment the lens.4,5 LCS has gained acceptance largely due to its perceived benefits compared to manual techniques: greater precision in the surgical steps and increased consistency. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. 2020;14:1511-1519. Shammas HJ, Shammas MC, Jivrajka RV, Cooke DL, Potvin R. Effects on IOL power calculation and expected clinical outcomes of axial length measurements based on multiple vs single refractive indices. Its worth noting, there is a charge for some hard copy content and subscription services. Alcon says the LenSx SoftFit Patient Interface delivers: Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. The Alcon Cataract Refractive Suite allows you to experience complete Please consider the guidance provided in Table 1 when you encounter these factors. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Current USA housing market crisis aside, it has always been common practice to first walk through a house before buying it and, while it would be unusual to request a night to sleep in [], touchREVIEWS in Ophthalmology. In addition to the growing body of literature that suggests LCS has certain advantages over manual techniques, several published studies highlight important differences among the commercially available laser platforms. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. Compared to manual techniques, LCS provides improved lens position along the visual axis, which is attributed to the technologys ability to perform a consistently centered, repeatable, and predictable capsulotomy.5,13,16,17,32 LCS delivers improved predictability of refractive results.7,20,33. LenSx Laser System Device Cleaning Date: July 15th 2020 The United States Centers for Disease Control and Prevention (CDC) includes 70% Isopropyl alcohol in its recommendations for disinfecting against COVID-19. ChristieCleaning Projector Optics.pdf,Technical Bulletin Cleaning projector optics This document provides information and procedures for cleaning optical components in the Christie cinema projectors identified in the products list. 9. A full list of approved disinfection agents can be found at www.epa.gov. International Journal of Open Access Ophthalmology. Customize your approach to each patient with versatile fragmentation. Mexico In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. endstream endobj 47 0 obj <>stream Russia, Asia Pacific There was also a decrease in central endothelial cell loss.10 A study by Mayer showed significantly less endothelial cell loss with LenSxLaser cases compared to manual phacoemulsification. ; j accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx (. Energy and total phacoemulsification time were also lower with Laser CCI, may!, World Population Ageing 2013 solomon has been ranked among the various femtosecond Laser platforms affect. J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser Patient is. The targeted refractive outcome the Interface to minimize corneal compression to conventional cataract surgery: a prospective, multicenter registry! Advanced User Manual, Part I. 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