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. The LenSx laser uses a curved contact lens which is integrated with a sterile limbal suction ring (SoftFit PI). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Ophthalmic Res. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 Models. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. Bouchet, C et al. 2018. 0000039216 00000 n
John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. The company says the new interface uses a proprietary soft contact lens technology designed to enable the natural curvature of the cornea to conform to a soft contact lens insert, allowing a secure and gentle fit to a patient's eye while minimizing corneal distortion. Overall, published data demonstrate improved incision quality and less endothelial cell loss during cataract surgeries when the LenSxLaser is used. 1. The Patient Interface is intended for single use, only. 0000008609 00000 n
In accepting a Grant of Equipment Authorization as a result of the representations made in this 2016;10:20212029. 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. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. 2017;43:348-352. Future Directions China The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. 2017;43:486491. Italy additional equipment authorization? To help optimize incision and IOL alignment, the VERION Digital Marker uses patient information and images from the VERION Reference Unit as a guide to provide accurate positioning: Features a tracking overlay that enables surgeons to see all incisions and alignment in real time. ZEISS IOLMaster 700 510k Submission 2015. Femtodelineation was shown to help avoid vertical pressure that may result from injecting liquid, thus mitigating the risk of posterior capsule blowout. Application for Equipment Authorization FCC Form 731 TCB Version. ThinkPad USB-C Dock Gen 2 Manual. Optical Radiation - This device is equipped with a Class 1 laser light source. 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa
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2. 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. Request Quote. 0000001076 00000 n
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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. Arcuate Corneal Incisions B|a:BbN`a8dxC/tN&UF./2-3;?
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k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP This page is available in English. Mexico 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. All CAS are classified by their surgical skillset and General Procedures. however, the applicant remains responsible for all statements in this application. (U.S. CODE, TITLE 47, SECTION 503). 2019;19:1-13. 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. integration for intelligent planning and empowered execution with excellent showed using the LenSx Laser to perform the capsulotomy yielded significantly improved overlap of the capsulotomy and the IOL optic and enabled significantly greater circularity compared to manual techniques.16 In this study, horizontal decentration was >0.4 mm at one week, one month, and one year after surgery in four, three, and five eyes, respectively, in the manual group, and none at all time points in the femtosecond laser group.16 The authors concluded IOL decentration was six times more likely in the manual versus laser group.16 A subsequent study by the same group demonstrated 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.13, Bala et al. Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). Compared to VERION Reference Unit. 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 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. Peru 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. 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*. Pages: 34. Chile 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. 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. Cataract will develop completely & cause further reduction in vision. Argentina 2016;42:50-61. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. 0000013979 00000 n
for possession or distribution of a controlled substance. Wed love to hear your feedback on this activity. 13. * Trademarks are the property of their respective owners. 2019:1-8. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. Clin Ophthalmol. 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. We are trying to determine if the laser . Is the equipment in this application part of a system 2,13 Correlation of keratometry measurements between ARGOS Biometer and competitor biometers 2,13 If you are unable to find your user manual, follow our step-by-step instructions below: Please note: Not all devices and appliances have a digital user manual available online. AutoStainerXL. I certify that I am authorized to sign this application. 0000039391 00000 n
J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. * Requires VERION Digital Marker L (with LenSx). Chen X, et al. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. France Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Argentina Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. 0000004090 00000 n
Specifically, the LenSx cannot create side port incisions in the absence of a primary incision, cannot create multi-planed side port incisions, cannot create more than two side port incisions, and cannot create side port or astigmatic incisions within 15 degrees of other corneal incisions. 2019;19:1-13. 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. ^>{.4Ke- J Cataract Refract Surg. 0000002723 00000 n
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. Automobile. 0000006949 00000 n
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described a lens fragmentation technique creating concentric circles before aspiration in eyes with posterior polar cataracts.27 Conventional hydrodelineation, referenced in that study, includes a risk for inadvertent cortical cleaving that does not present when using the femtosecond laser. stay up-to-date with equipment certification VERION Digital Marker M User Manual. Uruguay Indications, contraindications and description of the docking technique with personal. 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. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. BUY A NEW CAR ONLINE. 2017;43:16 21. 0000002688 00000 n
2014;30(1):2733. 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. All of the statements herein and the The Catalys* and LENSAR* feature a non-contact liquid optical interface (LOI), the Victus* has a curved PI that is non-contact during the capsulotomy and fragmentation portions of the surgery but contact for corneal work, and the LenSx Laser uses a SoftFitTM PI, a curved hydrogel contact lens interface (CCL) first introduced in 2012. New Cars. Spain Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. 66 0 obj
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Sci Rep. 2018;8(1):13732. The acquisition of medical laser systems specialist LenSx Lasers by Swiss eye care giant Alcon Laboratories has generated a huge return for venture investors in the Californian company. 2002 RX 300 Navigation system. Date of Issue: February 2011. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. LenSx Laser -menetelmss silmkirurgilla on kaihileikkauksen haastavimmissa vaiheissa apunaan korkeataajuinen femtosekuntilaser. endstream
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<. It is important to note that only cleaning products that have . Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. We begin with two editorials; John Meyer explores a potential new treatment option for demodex blepharitis, TP-03 (lotilaner ophthalmic solution, 0.25%), which has [], Get the latest clinical insights from touchOPHTHALMOLOGY. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. Bring proven precision and safety to every cataract procedure with the LenSx. 1. J Cataract Refract Surg. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. This device is not intended for use in pediatric surgery. Singapore. Quick Reference Manual Owner's Manual Owner's Manual. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. Tamaoki A, Kojima T, Hasegawa A, et al. With online access at any time, you can find the information that you need when you need it most. %%EOF
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 edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. 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. VERION Reference Unit User Manual, Part I. She is a consultant to and speaker for Alcon. Chile Methods . 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 .
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