A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. The Patient Interface is intended for single use only. 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. Caution: Data accurate at time of publishing, latest test results . application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID Laser Platform Interface The PI design is a critical differentiating factor in the various platforms. It may offer greater globe stability against pulsatile and ocular movements relative to noncontact interfaces, which may result in more consistent laser patterns and smoother morphology at the capsulotomy edge, compared to the Catalys* and Victus* systems.8 The fixation and stability of the eye with the SoftFitTM PI contributes to the LenSx Lasers ability to do high-quality, complex corneal work, while also being able to accurately and effectively perform capsulotomies and lens fragmentation. endstream endobj startxref Please consider the guidance provided in Table 1 when you encounter these factors. Clinical performance in continuous curvilinearcapsulorhexiscreation supported by a digital image guidance system. 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 non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. endstream endobj 46 0 obj <>stream hb``a``x 01G3020b^,Tp73\)0_Mp/7CaD Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. 13. Alcon equipment, Made up of tenured ophthalmic technicians 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. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Chile 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI That could rise more than two-fold to $744 million, provided sales . 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. endstream endobj 47 0 obj <>stream The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. See Prices; Nikon Camera Lens 17-55mm. 2018. Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). 0000028839 00000 n Comparison of the refractive outcomes in patients with dense nuclear cataract between the ARGOS Biometer and IOLMaster* 70012. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. 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. Knife-Cut. 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. 12. 64 0 obj <> endobj xref In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. AutoStainerXL. J Cataract Refract Surg. Uruguay the equipment identified hereon for use under the Commission's Rules and Regulations listed below. Design: Prospective, interventional case series. Unless stated otherwise for specific product or event pages, the content on this site is based on the regulatory and legal principles applicable to the United Kingdom. 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. Nagy Z. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Alcon recommends using Isopropyl as disinfectant. B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP specified in this application, (2) compliance statement labeling pursuant to the May 2019. Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. Cleanroom wipes, Lensx 90. United Kingdom - English, Americas 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. 2016;10:20212029. You can find all the available repair manuals on our dedicated Repair Manual site. Alcon Data on File 2019, report # SD-18-0001-670-01. and that the FCC reserves the right to contact the applicant directly at any time. JCataract Refract Surg. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. 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. 0000002575 00000 n SUV. Cataract will develop completely & cause further reduction in vision. Valved Entry System Valved cannula provides a closed system, eliminating the need for plugs and decreasing instrument exchanges EDGEPLUS blade delivers a flat linear incision Cannula removes easily from trocar after insertion without secondary instrument Low friction silicone valves designed for smooth instrument exchange Locking 41 0 obj <> endobj Ophthalmic Res. 0 0000089165 00000 n Santec Letter of Declaration. Select below for other countries. Get ready to discover the ARGOS Biometer the smart planning solution. John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. 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). 0000001076 00000 n Request Quote. Aperio ImageScope DX. The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. 2016;42:50-61. This page is available in English. John Davidson, MD, received compensation from Alcon for his contributions to this 2019;19:1-13. 2017;43:348-352. In accepting a Grant of Equipment Authorization as a result of the representations made in this 15. 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. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. But how does it differ from traditional methods for removing cataracts? LenSx Laser Important Product Information. The ARGOS Biometer utilises SS-OCT-enhanced keratometry with angle-to-angle, cornea-to-retina, real-time OCT guidance, allowing the user to monitor patient alignment and fixation and helping acquisition of accurate measurements every time. 2016;1(1):1-4. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. The rates of anterior capsule tear, posterior capsule tear (with or without vitreous loss), and posterior lens dislocation were all significantly lower after LenSx Laser LCS than rates reported for similar events among recipients of manual surgery.6, After implementing the SoftFitTM PI, anterior capsule tear was reduced to two of 2,621 cases (0.07%).18 Abell et al. 4 - Contraindicaciones. BMC Ophthalmol. Brazil LCS has been studied in a number of complicated cataract scenarios, including intumescent white cataracts, traumatic cataracts, and eyes with concomitant phacomorphic glaucoma.22,2426, One particular complicated patient type is the posterior pole cataract patient. 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. J Refract Surg. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. Cancel. 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). 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. Discard used Patient Interfaces as medical waste. User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. trailer <]/Prev 315881>> startxref 0 %%EOF 102 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. Mayer et al. (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 Italy All CAS are classified by their surgical skillset and 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. Poster presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. ae`Q J Cataract Refract Surg. It is not intended to provide information to the general public or medical advice. Italy Clin Ophthalmol. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. 0000008100 00000 n Roberts T V, et al. The ARGOS Biometer utilises SS-OCT-enhanced keratometry with angle-to-angle, cornea-to-retina, real-time OCT guidance, allowing the user to monitor patient alignment and fixation and helping acquisition of accurate measurements every time.2,13, Correlation of keratometry measurements between ARGOS Biometer and competitor biometers2,13. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Nikon AF-S Zoom-Nikkor Instruction Manual. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. The Patient Interface is intended for single use only. The applicant must certify that neither the applicant nor any party to the application 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. Compared to VERION Reference Unit. * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). * Trademarks are the property of their respective owners. ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c '\Qjqpl9<>4R . Evaluation and comparison of the new swept source OCT-based IOLMaster 700 with the IOLMaster 500. Pages: 34. 2019. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. The growing body of evidence on the use of LCS is consistently showing certain advantages over manual techniques, while noting differences among the platforms.6,7,13,18,19,32,36,41 Reported complication rates are low and may be platform-related rather than category-dependent. The microadhesions that were demonstrated in three cases in the LenSx group did not lead to intraoperative or postoperative complications. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 0000052525 00000 n Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. 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. Purpose . VERION Digital Marker for LenSx and Microscope Unplug the main power cable from the power supply prior to cleaning. 3. : Does the applicant or authorized agent so certify? Argentina E: [email protected]. Quick Guide Charging the Battery with the Charger Connecting to a Pc. Colombia hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). Its content should not be considered medical advice, diagnosis or treatment recommendations. ASP300 S. Operating Manual Instructions For Use Manual. Name of test firm and contact person on file with the FCC: WILLFUL FALSE STATEMENTS MADE ON THIS FORM ARE PUNISHABLE BY FINE AND IMPRISONMENT 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. Colombia 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 0KX%3`0'Xi V RakXk;3 (z`/Na88 addition to our existing device-specific directions for use and manuals of operation, Alconis 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 Wilcoxon signed rank test. This page is available in English. An Y, Kim H, Joo C-K. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. 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. 0000008498 00000 n 2020;14:1511-1519. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. Holladay et al. The common alternative used in other laser platforms is a noncontact liquid optical interface. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. Peru Only properly trained personnel with experience may operate the device and control software and interpret the results. y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! 0000015317 00000 n Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. Femtodelineation was shown to help avoid vertical pressure that may result from injecting liquid, thus mitigating the risk of posterior capsule blowout. Spain This device is not intended for use in pediatric surgery. Retrospective chart review of 231 patients for LenSx and manual groups. 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 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. Does this application include a request for confidentiality for any portion(s) of the data 0000039216 00000 n The Alcon Cataract Refractive Suite allows you to experience complete 0 reported on 77 eyes treated with the LenSx Laser and 57 eyes treated with manual techniques: 41.6 and 68.8% of the LCS group were within 0.25 D and 0.50 D of target refraction postoperatively, respectively, compared to 28.1 and 46.9% in the manual group, respectively.7 A greater percentage of patients were 0.50 SD in the LenSx Laser group. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. Singapore. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. DXX - Part 15 Low Power Communication Device Transmitter. 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.