LenSx Laser Cataract Surgery Description of product as it is marketed: Peru All CAS are classified by their surgical skillset and +*z#V|^1im!qAJ>iykmZ-WZj_$u5wqg Bh/4\G*B>Z\hP44Z"j#q]u%F&z d{T+#M9Ulewm.Z2JS lP,gx~G$G3{t~1`kB;UGH;gB'@L5*#r4af=uF+uB'pMA\U;d} uM=o7`gb\mZ"JF>efq1Y-i+k O,+W"mtyN-32X0.DhlJmR\Ub8H5,st?m9?=4S[LQ. |I 5 Optical Radiation - This device is equipped with a Class 1 laser light source. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. Ophthalmology. I certify that I am authorized to sign this application. A full list of approved disinfection agents can be found at www.epa.gov. PLOS ONE. ./&oWzSuCE|Kk9!bde1tmH&FQvj\C!P* Manual is suitable for 5 more products: Lumix DMC-FX12 DMC-FX10A - Lumix Digital Camera DMC-FX12S - Lumix Digital Camera DMCFX10S - Lumix Digital Camera DMC-FX12K - Lumix Digital Camera. @-{^jLz3lEwAS^ vF3ErB2UrAF n^N$13$~eer(q7&H"W&wIYJq-3:KOUw9`"tRj5=f@~Q+r lN?@E1>R=g3pNIm53SM$kI"V_L%uQ.,0azdtd~ufu{ahQ6g\N[r9+tS{rKB Chen X, et al. 0000089128 00000 n * Trademarks are the property of their respective owners. She is a consultant to and speaker for Alcon. Ecuador Each of these procedures may be performed either individually or consecutively during the same surgery. Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. VERION Reference Unit User Manual, Part I. 1. Ali MH, et al. endstream endobj 47 0 obj <>stream Clin Ophthalmol. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR 0000017756 00000 n 2017;43:348-352. 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. This platform is intended to provide general product information for education and illustration purposes. aZ.hgRo7 FGGYfR[ ARGOS Optical Biometer Important Product InformationCaution: Federal (USA) law restricts this device to the sale by or on the order of a physician. ZEISS IOLMaster 700 510k Submission 2015. Singapore. 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 2017;43:16 21. Alcon sponsored the publication of this promotional piece. %%EOF exhibits attached hereto, are true and correct to the best of my knowledge and belief. For relevant training content from industry thought leaders, LenSx Laser Important Product Information. This device is not intended for use in pediatric surgery. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Sci Rep. 2018;8(1):13732. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). 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). Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. Russia, Asia Pacific JCataract Refract Surg. LenSx, a form of cataract surgery that uses an advanced laser to make the necessary incision, removes those potential barriers to success and provides a less risky and more precise option for patients with cataracts. 2019:1-8. See Prices; Nikon Camera Lens 17-35mm. endstream endobj 92 0 obj <. China endstream endobj 42 0 obj <>/Metadata 2 0 R/Pages 39 0 R/StructTreeRoot 6 0 R/Type/Catalog>> endobj 43 0 obj <>/MediaBox[0 0 594.96 842.04]/Parent 39 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 44 0 obj <>stream 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. User Manual. J Refract Surg. 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. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. 2017. 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. This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. 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. 2006-2023 Lexus, a Division of Toyota Motor Sales, U.S.A., Inc. All information presented herein is based on data available at the time of posting, is subject to change without notice and pertains specifically to mainland U.S.A. vehicles only (may differ in the state of Hawaii, Puerto Rico, the U.S. Virgin Islands and in other regions). 2019. 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. 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. Santec Letter of Declaration. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). 3 - Instrumentacin y tcnica. Reproducibility and accuracy at every step. The laser platforms utilize either a contact or non-contact PI. 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. Shajari M, et al. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. 3yhr1-aF?3y;0ub0R a |Bg`9H36 _uG5 endstream endobj 65 0 obj <>>> endobj 66 0 obj >/PageWidthList<0 612.0>>>>>>/Resources<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 67 0 obj <> endobj 68 0 obj [/ICCBased 93 0 R] endobj 69 0 obj <>stream and that the FCC reserves the right to contact the applicant directly at any time. Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? Innovation in the surgical platform technology is ongoing. 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. 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. 1. The interface gently makes contact rather than first fitting a suction ring directly onto the patients eye followed by docking the patient up to the laser objective head.40, Some platforms possess a fixed bed, which can help stabilize the head during image capture and treatment, but brings with it the necessity of moving a patient to another bed for the remainder of the surgery.19. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. 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. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced 2016;42:50-61. 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI Show all Leica Laboratory Equipment manuals. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. May 2018 in COMPLIANCE. authorization which includes information to enable the agent to respond to the above section Uruguay Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. 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. 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. ^>{.4Ke- 0000089165 00000 n Poster presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. 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. 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. Toric Lenses with Manual Marking. noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. 2 - Software LenSx Cornea. 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. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. 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. B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP 2017;33(10):708712. Sci Rep. 2018;8(1):13732. Europe / Middle East / Africa France 2018. J Refract Surg. Tamaoki A, Kojima T, Hasegawa A, et al. * Trademarks are the property of their respective owners. 2017;67(10):1574 1579. An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. Laser Platform Interface View the latest owner's manuals for your car. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). Russia, Asia Pacific Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. Check if a local MyAlcon page for your country to access country product information. 7. hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L Shammas HJ, Ortiz S, Shammas MC, et al. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. 138 0 obj <> endobj During femtosecond laser lens fragmentation, a beam spot size of less than 6 m is used to generate plasma in the ocular tissue.19 This plasma, containing free electrons and ionized molecules, expands to cause a cavitation and formation of a bubble that expands and contracts to cause tissue separation,4,19 thereby reducing the amount of phacoemulsification energy delivered compared with manual techniques. Omoto MK, Torii H, Masui S, Ayaki M, Tsubota K, Negishi K. Ocular biometry and refractive outcomes using two swept-source optical coherence tomography-based biometers with segmental or equivalent refractive indices. Arcuate Corneal Incisions 2017;43:15711574. PLoS ONE. Filkorn et al. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. Alcon, Inc. (NYSE: ACL) announced today that it has entered into a definitive agreement to acquire LenSx Lasers, Inc, a privately held company that developed the first femtosecond laser to receive U.S. Food and Drug Administration (FDA) clearance for use as a part of cataract surgery.The LenSx system is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery . 1993 ES300. Request Sample. AutoStainerXL. Rayon / Hemp. Aperio GT 450. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. Europe / Middle East / Africa "H Djd3X$v H(q The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. MOVU ARGOS 510(k) Summary 2019. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. Of note, five of the anterior capsule tears occurred in cases in which the curved, rigid interface was used and only two in which the SoftFitTM PI was used (p=0.007). Colombia 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. VERION Digital Marker User Manual. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. (U.S. CODE, TITLE 47, SECTION 503). endstream endobj startxref 2018. 2019;19:7. Select below for other countries. endstream endobj 46 0 obj <>stream This can make seeing at night especially difficult. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. These were not seen with the other laser platforms.8 The SoftFitTM PI in the later generation of the LenSx Laser platform was thought to have caused less deformity and unimpeded laser transmission.8 The SoftFitTM PI, combined with the LenSx Laser devices proprietary variable numeric aperture, may help control for pulsatile eye movements as compared to a LOI.8. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. 0000052525 00000 n * Trademarks are the property of their respective owners. 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. 64 39 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 LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. 1 and its accessories. 0000058734 00000 n While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. Yeu E, et al. December 2018. I am equally certain the growing body of literature confirms this belief. J Refract Surg. Chen M, Seagrave Z, Patrianakos T, et al. 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. Its content should not be considered medical advice, diagnosis or treatment recommendations. 0000039391 00000 n 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. Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. 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. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 1 - Introduccin al LASIK y la ciruga corneal. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. Discard used Patient Interfaces as medical waste. Automobile. Spain Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. 3. Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. 2019 ASCRS ASOA Annual Meeting. Other systems may take more total suction time, depending on both platform and programmed degree of lens softening.19,40 Of the LCS platforms, only LenSx Laser offers a single-piece PI without the need for water. Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. Hong Kong Lensx 90 is 100% cleanroom lens cleaning wipe & tissue. Alcon LenSx User Manuals User manual instruction guides for Alcon LenSx devices. however, the applicant remains responsible for all statements in this application. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. The surgical correction of astigmatism is challenging. 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. Any reproduction, dissemination, or distribution of this document in whole or in part without prior written permission of LenSx is strictly prohibited. precision at every step. Show all featured manuals. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. Weight: 9 lbs: Dimensions: 24 24 24 in: Item Number: 2019;19:1-13. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. !?+;t>Z -X;WVk5H' >tWs7uR-/7hszE^,! * Requires VERION Digital Marker L (with LenSx). 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. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. 2016;42:14701476. 0000013979 00000 n VERION DigitalMarker . 4. Is the equipment in this application part of a system Ecuador 0000001520 00000 n Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms. Holladay et al. Purpose . "EtA0lX&X5"@$AKz`[H5 q@o~HW? : User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. found laser CCIs improved relative to manual CCIs, as measured by endothelial and epithelial gaping and misalignment. 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. Lens Fragmentation Br J Ophthalmol. Generational improvements in software and hardware have already produced additional laser patterns, auto pre-positioning, speed and improvements in the PI, the latter of which confers greater control of the globe and more precise laser delivery. 2020;14:1511-1519. United Kingdom - English, Americas View the latest owner's manuals for your car. and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to Latest Offers. The remaining characters of the FCC ID, 8065998162, are often associated with the product model, but they can be random. * Retrospective chart review of 225 patients for LenSx and manual groups. 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 70 % rayon and 30 % manila hemp, SECTION 503 ) avoid. 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