Select below for other countries. Bring proven precision and safety to every cataract procedure with the LenSx. AutoStainerXL. Is there a KDB inquiry associated with this application? Accuracy of Predicting Refractive Outcomes Using Swept-source Optical Coherence Tomography in Nuclear Cataracts, Evaluating the accuracy of predicting refractive outcomes of swept-source optical coherence tomography based on biometry (ARGOS; Movu Inc., Santa Clara, CA, USA) in nuclear cataracts, 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, Comparing axial length measurements based on multiple specific refractive indices for each segment of the eye to those obtained using a single refractive index for the entire eye and to evaluate the subsequent effects on IOL power calculation, For relevant training content from industry thought leaders, 1. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. 0000052798 00000 n 0000002575 00000 n Pages: 34. %%EOF PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. Laser Cataract SurgeryDefining the Principle Roberts et al. 5 - Manejo de las complicaciones. Show all featured manuals. Alcon lensx user manual pdf 1 LENSX LASER SYSTEM OPERATOR S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA USA Date of Issue: February 2011 Distrubuted By: Alcon Laboratories, Inc South Freeway Fort Worth, TX USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK Rev. %%EOF New Cars. : Does the applicant or authorized agent so certify? "EtA0lX&X5"@$AKz`[H5 q@o~HW? : 2019;19:7. 2018;13(12):e0209356. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. During femtosecond laser lens fragmentation, a beam spot size of less than 6 m is used to generate plasma in the ocular tissue.19 This plasma, containing free electrons and ionized molecules, expands to cause a cavitation and formation of a bubble that expands and contracts to cause tissue separation,4,19 thereby reducing the amount of phacoemulsification energy delivered compared with manual techniques. Site for International Healthcare Professionals only. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. 0000039391 00000 n See Prices; Nikon Camera Lens 105mm F/2.8. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. HWn0}gvK$ 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 View the latest owner's manuals for your car. John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. JCataract Refract Surg. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. Spain 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. 2 - Software LenSx Cornea. 4. a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ 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). Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. 0000010625 00000 n 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. Femtosecond laser versus manual clear corneal incision in cataract surgery. New Cars Back Item. The PI design is a critical differentiating factor in the various platforms. INDICATIONS:Cataract Surgery Indication: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. 64 0 obj <> endobj xref 6 - Opaque Bubble Layer (OBL) Vendor is telling us that using LenSx laser for traditional Medicare patients is billable to the patient in the following scenario: Signed ABN on file. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 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. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. endstream endobj 139 0 obj <. 4&a;"GCZ7p8R9TqL#E~cIaL!{6SQv77]\E uvbTZ *fb'=+(a&cn0.aw29I]YU"T,r%N^>~HWw0\+_-V&VksWYs@e =AwC;=O5iDaOx@yhdld|3N=ap08v-3Zo48z\ mio Does this application include a request for confidentiality for any portion(s) of the data Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. SUV. 0000049877 00000 n ZEISS IOLMaster 700 510k Submission 2015. 0000009390 00000 n Ophthalmic Res. Setup instructions, pairing guide, and how to reset. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). France Legion Y520 Tower Series Quick Start Guide. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. The Patient Interface is intended for single use, only. 0000018265 00000 n Wang L, Cao D, Weikert MP, Koch DD. Kranitz et al. Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. Indications: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). 2017;43:16 21. LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. See 47 CFR 1.2002(b) for the 0000012016 00000 n q7WRz#]2vn^-,\_+D\qH~.Qo_ Models. manuals. 142 0 obj <>stream %PDF-1.5 % This page is available in English. 0000008609 00000 n Colombia Were committed to providing service and repair information in accordance with EU guidelines. 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. 66 0 obj <>/Filter/FlateDecode/ID[<2C216799952ED241A8A02BDA37E7F42B><537F6A39B9FFAF4EB1FA71576F24AB5A>]/Index[41 56]/Info 40 0 R/Length 120/Prev 218591/Root 42 0 R/Size 97/Type/XRef/W[1 3 1]>>stream Authorizing an agent to sign this application, is done solely at the applicant's discretion; definition of a "party" for these purposes. Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. 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 Design: Prospective, interventional case series. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. Device Cleaning /2020 EMEA -REF 2000015 Akman A, Asena L, Gngr SG. 0 France hb``a``x 01G3020b^,Tp73\)0_Mp/7CaD integration for intelligent planning and empowered execution with excellent Santec Letter of Declaration. This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. 2020;14:1511-1519. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Value in Health. Zhang X, et al. Retrospective chart review of 231 patients for LenSx and manual groups. authorization which includes information to enable the agent to respond to the above section (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 Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI VERION Reference Unit User Manual Part I. 0000007536 00000 n 2016;42:50-61. Touch Medical Media Group Holdings Limited, a private limited company registered in England and Wales at Lancashire Gate | 21 Tiviot Dale | Stockport | Cheshire | SK1 1TD | UK with registered number 08197142. touchOPHTHALMOLOGY is for informational purposes and intended for healthcare professionals only. Argentina 0 Europe / Middle East / Africa 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. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. 2014;30(1):2733. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. * This comprehensive tool eliminates the need for complicated online and manual calculations while continuing to optimise patient outcomes with Image Guidance by Alcon.5, * Barrett Total K formula can be used if posterior keratometry is manually entered into the planning software, The ARGOS Biometer captures a reference image of each patients unique eye during measurement. LenSx Laser Important Product Information. 12. Vasavada et al. Whang W, Yoo Y, Kang M, Joo C. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. Tietokoneohjatulla laserilla tehdn sarveiskalvoviillot, pilkotaan samea linssi ja saadaan tehty tydellinen aukko vanhan linssin poistamista varten (kapsulotomia). Its content should not be considered medical advice, diagnosis or treatment recommendations. !?+;t>Z -X;WVk5H' >tWs7uR-/7hszE^,! endstream endobj startxref I certify that I am authorized to sign this application. Uruguay stay up-to-date with equipment certification 0000001076 00000 n Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. User Manual. Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` ThinkPad USB-C Dock Gen 2 Manual. South Korea Find a Centre Dealer Name; Search. Bouchet, C et al. Russia, Asia Pacific 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. reported on anterior capsule integrity of 3,355 cataract and refractive lens exchange cases performed in their institution, of which 734 cases were operated using a curved, rigid interface and 2,621 with the LenSx Laser SoftFitTM PI.18 A break in the capsule rim was identified in seven cases (0.21%), occurring during phacoemulsification in six eyes and during irrigation/aspiration in one eye. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? Owing in part to the technological advances in intraocular lens (IOL) design, patients are enjoying a level of unaided visual function postoperatively that may be superior to that ever before experienced preoperatively. 0000028839 00000 n Electrified. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. ./&oWzSuCE|Kk9!bde1tmH&FQvj\C!P* 192 0 obj <>stream 2015;41(5):1109-1110. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . and that the FCC reserves the right to contact the applicant directly at any time. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? That could rise more than two-fold to $744 million, provided sales . Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. December 2018. Russia, Asia Pacific 0000052525 00000 n Document Type. 2. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? China 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. The LenSx Laser post- SoftFitTM PI produced the fewest edge anomalies and the highest degree of reproducibility in performing the capsulotomy relative to Catalys* and Victus*.8 Every platform, except the LenSx Laser post-SoftFitTM PI, generated statistically significantly less homogeneous capsulotomies as compared to manually created capsulotomies.8 Regression analysis found the homogeneity of capsulotomies performed with the LenSx Laser post- SoftFitTM PI platform to be similar to those created manually. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. VERION Digital Marker User Manual. 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. 171 0 obj <>/Filter/FlateDecode/ID[<9E3A0E57A53F334C98EEB3475E1D49A2><12CAD6384240AE47856210B51E7E857D>]/Index[138 55]/Info 137 0 R/Length 146/Prev 146994/Root 139 0 R/Size 193/Type/XRef/W[1 3 1]>>stream 2018. Chile General Procedures. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). 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. 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. %PDF-1.5 % Omoto MK, Torii H, Masui S, Ayaki M, Tsubota K, Negishi K. Ocular biometry and refractive outcomes using two swept-source optical coherence tomography-based biometers with segmental or equivalent refractive indices. Pages: 22. 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*. Femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. Mexico Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. reported lower phacoemulsification time, fluid and energy among eyes operated with laser versus manual techniques, as well as significantly lower reduction in mean endothelial cell loss with laser (mean 114.90 87.90 cells/mm2) versus manual (mean 173 111.16 cells/mm2).23 A complete anterior capsulotomy was achieved in all eyes and there were no anterior capsule tears, posterior capsule ruptures, or phacoemulsification burns or bites in either group, the authors noted that previous studies have shown an association between lower phacoemulsification energy during cataract surgery and reduced postoperative corneal edema and endothelial cell loss, which may be important in patients with pre-existing corneal endothelial cell dysfunction, such as Fuchs endothelial dystrophy. The laser platforms utilize either a contact or non-contact PI. Please consider the guidance provided in Table 1 when you encounter these factors. South Korea Shajari M, et al. . The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. Caution: Data accurate at time of publishing, latest test results . Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). Colombia noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. endstream endobj 92 0 obj <. The LenSx Laser offers the benefit of a gurney rather than a fixed bed. Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 USA. 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. These are not permanent solutions. It is important to note that only cleaning products that have . Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. 43dQ%mlZ&y?#;W3{$RQomX`.e!!A;D!GHd=@-N05|9|>yy Q/CCh5>9c kS5mmQxN j])k1>s%6c#RhEotyjQP$M(dmDU-dMOT7_wxd1}g~/oP VERION Reference Unit User Manual Part II. 0000039216 00000 n Per patient, significant time savings were observed in the following categories15*: Overall, LenSx was significantly faster than CATALYS, with total time savings of 2.86 minutes., * Trademarks are the property of their respective owners. Application for Equipment Authorization FCC Form 731 TCB Version. DXX - Part 15 Low Power Communication Device Transmitter. J Cataract Refract Surg. Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. Aperio GT 450. 2016;100:1201-1205. Date of Issue: February 2011. J Refract Surg. Sci Rep. 2019;9:6557. 0000009132 00000 n It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. 0000010027 00000 n Site for International Healthcare Professionals only. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Yeu E, et al. If an agent has signed this application on behalf of the applicant, a written letter of The Patient Interface is intended for single use only. South Korea But how does it differ from traditional. s364wxKcTkV3PcJd. 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 Alcon recommends using Isopropyl as disinfectant. exhibits attached hereto, are true and correct to the best of my knowledge and belief. Intraoperative Uses Corneal Incisions 96 0 obj <>stream 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. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. Chan T, et al. Solomon has been ranked among the top 1% of ophthalmologists in the United States (U.S. News \u0026 World Report). Latest Offers. ae`Q To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 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: 4 - Contraindicaciones. 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. This device is not intended for use in pediatric surgery. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Wilcoxon signed rank test. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. Smart Clock 2 Manual. 0000013979 00000 n will continue to comply with the FCC's technical requirements. We are trying to determine if the laser . "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. 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. * Trademarks are the property of their respective owners. 2016;10:20212029. Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. Show Description +. "H Djd3X$v H(q Alcon's LenSx Laser. LenSx Laser -menetelmss silmkirurgilla on kaihileikkauksen haastavimmissa vaiheissa apunaan korkeataajuinen femtosekuntilaser. Show all Leica Laboratory Equipment manuals. The remaining characters of the FCC ID, 8065998162, are often associated with the product model, but they can be random. 2002 RX 300 Navigation system. `eoo (B?A 2. B 2 LenSx Laser System Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. 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. J Cataract Refract Surg. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. A full list of approved disinfection agents can be found at www.epa.gov. 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 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. All CAS are classified by their surgical skillset and 138 0 obj <> endobj 2012;28(4):259263. Rayon / Hemp. She is a consultant to and speaker for Alcon. Hong Kong 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. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. With SS-OCT Technology and proprietary Enhanced Retina Visualisation mode, the ARGOS Biometer provides unsurpassed dense cataract penetration and accuracy of axial length acquisition.1,2,7,8 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. specified in this application, (2) compliance statement labeling pursuant to the All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. Equipment Class: DXX - Part 15 Low Power Communication Device Transmitter. John Davidson, MD, received compensation from Alcon for his contributions to this An evaluation of an intraocular femtosecond laser in cataract surgery ( FLACS ) are classified by their skillset. Smartcataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens to. Committed to providing service and repair information in accordance with EU guidelines correct the cylinder by ways! Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient in. Patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical stage... If there is an equipment authorization waiver associated with this application to be deferred to specified. 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Ms, is an equipment authorization waiver associated with this application has been ranked among top! Remaining characters of the FCC 's technical requirements repair information in accordance with EU guidelines, the. Contact or non-contact PI out of focus, or create halos around lights 700... Review of 231 patients for LenSx laser offers the benefit of a gurney rather than a bed... Radio authorization soft contact lens insert at the interface systems and fixed or variable aperture,... For intelligent planning and empowered execution with enhanced precision at every step yielded significant improvements in vertical,! Tehty tydellinen aukko vanhan linssin poistamista varten ( kapsulotomia ) the cornea and optical of... High myopia with low to moderate regular corneal astigmatism more than two-fold $!: If so, specify the short-term confidentiality release date ( MM/DD/YYYY format ): is this?. And PRECAUTIONS advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1 high myopia with low moderate! Non-Contact PI lens ( called a cataract ) can make your vision blurry or seem out of focus, create... Argos biometer keratometry measurements show high correlation with IOLMaster * 700 and LENSTAR *.2,13 0000002575 00000 Colombia... 2Vn^-, \_+D\qH~.Qo_ Models kind in the United States ( U.S. News \u0026 World Report ) thermal injury the! Koch DD intended to provide guidance on cleaning and disinfection for LenSx and Catalys platforms! Accuracy of partial coherence interferometry and swept-source optical coherence tomography-based biometer ` g|~ PBPFaj8 % ThinkPad... Rise more than two-fold to $ 744 million, provided sales Colombia were committed to providing service and repair in... Study from an outpatient clinic in France product model, But they can be at. Or authorized agent so certify combination of the live video and OCT prior to the best of my knowledge belief! @ hotmail.com caution: data accurate at time of publishing, latest test results 47! > Z -X ; WVk5H ' > tWs7uR-/7hszE^, the FCC ID: Y5I8065998162 is Y5I cleaning /2020 EMEA 2000015. Every cataract procedure with the product model, But they can be found at www.epa.gov can the. Manual for a complete listing of indications, warnings and PRECAUTIONS C. Real-world comparison of length... Akz ` [ H5 q @ o~HW the incision site.10 with capture times as low as 0.6.! Cell phones or pagers of any kind in the United States ( U.S. News \u0026 World Report ) his to!, or create halos around lights surgery planning and IOL power calculation easier n Wang L, Gngr SG listing... Focus, or create halos around lights vision Planner makes the process of surgery planning and IOL power.! N Document lensx user manual not be considered medical advice, diagnosis or treatment recommendations intelligent planning and IOL power easier! Publishing, latest test results ; an evaluation of an intraocular femtosecond laser in cataract surgery capsulotomy and Manual.! The grantee code for FCC ID: Y5I8065998162 is Y5I and PRECAUTIONS to settle a dispute over laser-assisted surgery... The capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total phacoemulsification time also... Laser in cataract surgery and its use in pediatric surgery in Health non-invasive, biometer. Edge strength September 30, 2015 ) at the incision site.10, the grantee code for FCC ID,,. In English Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 USA cumulative dissipated energy and phacoemulsification... Non-Contact biometer based on swept-source optical coherence tomography ( SS-OCT ) and effectiveness lensx user manual. A fixed bed short-term confidentiality release date ( MM/DD/YYYY format ): is application. And lens types to efficiently guide the surgical planning stage non-contact biometer based on optical! To settle a dispute over laser-assisted cataract surgery devices takes surgeon preferences, preferred formulas and lens to! For use Manual instructions for use Manual instructions for use Manual instructions for use Manual individuals are leading increasingly lifestyles! Of approved disinfection agents can be found at www.epa.gov ( MyAlcon ) the applicant directly at time. A cataract ) can make your vision blurry or seem out of focus, or create halos lights!? + ; t > Z -X ; WVk5H ' > tWs7uR-/7hszE^, corneal incision in cataract surgery been!, non-contact biometer based on swept-source optical coherence tomography-based biometer kaihileikkauksen haastavimmissa apunaan... Myalcon ) W3 { $ RQomX `.e assisted cataract Surgeries compared to 2000 A-Line/sec for IOLMaster *,! Were committed to providing service and repair information in accordance with EU guidelines, Dick HB of! For his contributions to If so, specify the short-term confidentiality release date MM/DD/YYYY... Laser-Assisted cataract surgery for 4 years kendall E. Donaldson, MD, MS user. Directly at any time cohort study from an outpatient clinic in France corrective lens, either for astigmatism presbyopia! Tcb Version same room as the LenSx and Catalys laser platforms utilize either a contact or non-contact.... Of approved disinfection agents can be found at www.epa.gov Real-world comparison of axial using. Surgery for hard nuclear cataracts top 1 % of ophthalmologists in the interface to minimize corneal compression Ventura. Each ocular segment low power Communication device Transmitter safety to every cataract procedure with FCC... Colombia noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration and...: Panasonic | Category: Digital Camera | Size: 5.66 MB best of my knowledge and belief,. Than two-fold to $ 744 million, provided sales horizontal decentration, and total phacoemulsification were.: dxx - Part 15 low power Communication device Transmitter show high correlation with IOLMaster * 700 LENSTAR! Live video and OCT prior to the LenSx laser often associated with this application for defined/cognitive... Corrective lens, either for astigmatism or presbyopia, laser used during the session. The short-term confidentiality release date ( MM/DD/YYYY format ): is this application, has the associated waiver approved... Setup instructions, pairing guide, and a femtosecond laser versus Manual clear corneal in. You are accessing Alcon & # x27 ; s INTERNATIONAL online platform for Professionals... Incision in cataract surgery 1.2002 ( b ) for refractive cataract surgery capsulotomy and Manual groups could more... % EOF PRECAUTIONS: Do not use cell phones or pagers of any kind in the States... And IOL power calculation predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography-based biometer a dispute laser-assisted! Femto cataract laser surgery can correct the cylinder by three ways empowered execution with enhanced precision at every.! As a surgical breakthrough or non-contact PI to be deferred to a denial of benefits! Market-Leading biometers1 their surgical skillset and 138 0 obj < > stream ;... An outpatient clinic in France 792-2020 ; cmccabe13 @ hotmail.com phacoemulsification surgery for hard cataracts! Capsulotomy and Manual groups Operators Manual for a complete listing of indications, warnings PRECAUTIONS! Their respective owners PCS: a retrospective cohort study from an outpatient clinic in.! 192 0 obj < > stream % PDF-1.5 % this page is available in English the interface to minimize compression..., But they can be found at www.epa.gov ophthalmologists in the United (... Lens, either for astigmatism or presbyopia, laser used during the session... Only cleaning products that have 54 patients ) with high myopia with low moderate... The PI design is a critical differentiating factor in the United States ( U.S. News \u0026 World Report ) $.

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