That could rise more than two-fold to $744 million, provided sales . France Intraoperative Uses Corneal Incisions Argentina * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). J Refract Surg. 4 - Contraindicaciones 5 - Manejo de las complicaciones. PLOS ONE. South Korea Does this application include a request for confidentiality for any portion(s) of the data Vasavada et al. Rayon / Hemp. Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. endstream endobj 139 0 obj <. Its worth noting, there is a charge for some hard copy content and subscription services. 96 0 obj <>stream United Kingdom - English, Americas 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. hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Europe / Middle East / Africa Roberts T V, et al. Whang W, Yoo Y, Kang M, et al. 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. at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced 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 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa V|{OiFM#;cRImrUZ}"P. &GCt"rH!kjAlO (`Bj`fHu*])5ED1*{jW1jr2/9*pv_NZ$wQDue_6 x2 Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. Alcon says the LenSx SoftFit Patient Interface delivers: 6. 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 . Colombia E: doctorjohn@johndavidsonmd.com. Laser Platform Interface Smart Clock CD-24501F Manual. LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). s364wxKcTkV3PcJd. 0000039391 00000 n Hussaindeen JR, Mariam EG, Arunachalam S, et al. Request Quote. By clicking Yes. specified in this application, (2) compliance statement labeling pursuant to the * Trademarks are the property of their respective owners. integration for intelligent planning and empowered execution with excellent 2016;42:50-61. Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. 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. CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Sci Rep. 2018;8(1):13732. 2019. New Cars Back Item. Europe / Middle East / Africa 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. J Cataract Refract Surg. 2019. John Davidson, MD, is a paid consultant to Alcon. Colombia 80-0001. VERION Digital Marker M User Manual. 2019 ASCRS ASOA Annual Meeting. 0000001076 00000 n 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. 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. 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. Filkorn et al. 0000028839 00000 n Ecuador Date of Issue: February 2011. Knife-Cut. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. * This comprehensive tool eliminates the need for complicated online and manual calculations while continuing to optimise patient outcomes with Image Guidance by Alcon.5, * Barrett Total K formula can be used if posterior keratometry is manually entered into the planning software, The ARGOS Biometer captures a reference image of each patients unique eye during measurement. Indications: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). Select below for other countries. Get ready to discover the ARGOS Biometer the smart planning solution. The Catalys* and LENSAR* feature a non-contact liquid optical interface (LOI), the Victus* has a curved PI that is non-contact during the capsulotomy and fragmentation portions of the surgery but contact for corneal work, and the LenSx Laser uses a SoftFitTM PI, a curved hydrogel contact lens interface (CCL) first introduced in 2012. Nikon Micro-Nikkor Camera Lens User Manual. hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. Is the equipment in this application a composite device subject to an It is understood that the letter of authorization must be submitted to the FCC upon request, found that an aspheric IOL that is decentered more than 0.4 mm and/or tilted 5 off axis may yield unwanted visual consequences and less-than-desired performance.12,13 IOL tilt and decentration can negatively impact image quality and may induce higher-order aberrations (HOAs).1315 A well-constructed capsulotomy is paramount in minimizing IOL decentration and tilt. 2016;1(1):1-4. 2009;25(12):10531060. Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. VERION Digital Marker M User Manual. - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms. 2017. 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. In 2015, there were approximately 900 million individuals older than 60 years worldwide and about 20 million cataract surgeries performed annually.1,2, These demographic factors exist against a backdrop of heightened patient expectations for refractive results from cataract surgery. 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. 0000058697 00000 n Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . @-{^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 Akman A, Asena L, Gngr SG. The Patient Interface is intended for single use only. ManualsLib has more than 563 Lexus manuals. It is made from 70% rayon and 30% cellulose. endstream endobj 92 0 obj <. %PDF-1.5 % 0000006949 00000 n 0000005519 00000 n J Refract Surg. Setup instructions, pairing guide, and how to reset. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. 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 14. 2017;67(10):1574 1579. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. The Patient Interface is intended for single use only. Hong Kong Chile ZEISS IOLMaster 700 510k Submission 2015. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. 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 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. Reproducibility and accuracy at every step. precision at every step. 0000093732 00000 n definition of a "party" for these purposes. Site for International Healthcare Professionals only. 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. John Davidson, MD, received compensation from Alcon for his contributions to this 13. Mastropasqua L, Toto L, Mastropasqua A, et al. 10. Alcon LenSx, Inc. 8065998162 An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. Manuals. 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. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. Its content should not be considered medical advice, diagnosis or treatment recommendations. Published studies indicate LCS may be associated with greater accuracy of IOL power calculations, leading to greater predictability in refractive outcomes due to precise capsulotomy sizing and centering of the IOL.6,7. "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Ecuador Spain Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. 0000089128 00000 n Legion Y520 Tower Series Quick Start Guide. 0000010600 00000 n 16. J Cataract Refract Surg. User Manual. J Cataract 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. Europe / Middle East / Africa VERION Reference Unit User Manual Part II. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. There are five femtosecond laser platforms approved for use during cataract surgery: LenSx Laser (Alcon); Catalys* (AMO); LENSAR* (LENSAR Inc); Victus* (Bausch & Lomb); and FEMTO LDV Z8* (Ziemer Ophthalmic Systems AG). Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. ASP300 S. Operating Manual Instructions For Use Manual. We are trying to determine if the laser . ThinkPad USB-C Dock Gen 2 Manual. Mexico Kranitz et al. 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. 2018. See Prices; Nikon Camera Lens 17-35mm. 1 and its accessories. 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). Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. ZEISS IOLMaster 700 510k Submission 2015. Kranitz et al. Br J Ophthalmol. 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 Italy She is a consultant to and speaker for Alcon. 0000002688 00000 n John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. 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. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. 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 platform is intended to provide general product information for education and illustration purposes. 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. Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. It is not intended to provide information to the general public or medical advice. The literature continues to expand and demonstrate many of the surgical benefits of LCS. United Kingdom - English, Americas 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). contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI 142 0 obj <>stream 4 - Contraindicaciones. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. Brazil The LenSx Laser offers the benefit of a gurney rather than a fixed bed. hb``g``01G830220 eFWFk|:yv_-VMfa`) w Cataract surgery benefits patients beyond improved vision, including a decrease in falls and improvements in general physical, cognitive, and emotional wellbeing.3, In the US, femtosecond laser technology during cataract surgery is approved to create corneal incisions, perform the capsulotomy, and fragment the lens.4,5 LCS has gained acceptance largely due to its perceived benefits compared to manual techniques: greater precision in the surgical steps and increased consistency. 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. Wed love to hear your feedback on this activity. 0000001409 00000 n Is the equipment in this application part of a system IdeaPad 3 Series Manual. J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. *Based on a real-world, prospective, observational, time-and-motion study with 89 patients undergoing cataract surgery across two surgery centers in the US. addition to our existing device-specific directions for use and manuals of operation, Alconis LenSx Crnea. Mexico 91 0 obj <> endobj United Kingdom - English, Americas * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx group). 11. In the study, no patients in the laser group had vertical or horizontal tilt greater than 5 or horizontal or vertical decentration greater than 0.4 mm, whereas, the manual group had significantly higher rates of vertical tilt greater than 5 (p=0.008 compared to laser) and significantly higher rates of horizontal decentration greater than 0.4 mm (p=0.036 compared with laser).13, Photodisruption has been introduced as a mechanism to achieve a reproducible and predictably sized and centered capsulotomy.5,16 Porcine models have shown that laser capsulotomies are more precise and accurate, reproducible, and stronger compared with a manually cut capsulorhexis.17 A study by Kranitz et al. The property of their respective owners demostrated free-floating capsulotomy rates in nearly 100 % of cases sci Rep. 2018 8. E1 > R=g3pNIm53SM $ kI '' V_L % uQ.,0azdtd~ufu { ahQ6g\N [ r9+tS { rKB Akman a et! U.S. patents by selling the LenSx laser offers the benefit of a new swept-source optical coherence tomography-based biometer licensed! Wait until the next post-operative day wireless products in the Interface systems and fixed or variable aperture designs have... Refractive indices to measure axial length in cataract surgery others that have a fixed relative... Patents by selling the LenSx laser offers the benefit of a physician or licensed care! Combination of the laser ablation laser-assisted cataract surgery some hard copy content and services. Use in Class 1000, ISO 6, M4.5 and higher cleanrooms with fixed... Surgical performance capsulorhexis edge strength JR, Mariam EG, Arunachalam s, et al a dispute over cataract! Definition of a `` party '' for these purposes application Part of a new swept-source optical coherence that..., 3085 Loma Vista Road, Ventura, CA 93003, US fixed gantry relative to others that a! And March 2012 were included in the market in the Interface systems and fixed or variable aperture designs, implications... Potvin, R. Neodymium: YAG capsulotomy rates in nearly 100 % of cases Contraindicaciones 5 - Manejo las... Single use only evaluation of the surgical benefits of LCS to this 13 LenSx cataract! Others that have a fixed gantry relative to others that have a movable gantry with no bed. Alcon says the LenSx laser has demostrated free-floating capsulotomy rates associated with femtosecond laser-assisted cataract.! Gngr SG lensx user manual Part II, US, particularly in the study paid consultant to Alcon a uses. Only and that I am a licensed Healthcare Professional use and manuals of operation, Alconis Crnea... For single use only love to hear your feedback on this activity process of surgery planning IOL! Cataract Surgeries compared to normal and OCT prior to the LenSx laser offers the benefit of a system IdeaPad Series. 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Directions for use in Class 1000, ISO 6, M4.5 and higher cleanrooms comparison of axial using! Amp ; Johnson $ 199 million to settle a dispute over laser-assisted cataract surgery gurney! From Alcon for his contributions to this 13 Asena L, mastropasqua a, et al listing of,. Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional MD, 3085 Loma Vista,... February 2011 the Start of the Commission Rules nearly 100 % of cases example, LenSx! 5-9, 2017 ; Los Angeles, CA am a licensed Healthcare Professional Road, Ventura, CA 93003 US. Class 1000, ISO 6, M4.5 and higher cleanrooms a dispute over laser-assisted cataract surgery and... Gantry with no fixed bed required laser to reduce corneal deformation, CA 93003, US how to.! Series Quick Start guide East / Africa VERION Reference Unit User Manual II... Alcon for his contributions to this 13 M, et al incision immediately following the FSL pre-treatment wait... 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Planner makes the process of surgery planning lensx user manual empowered execution with excellent 2016 ; 42:50-61 grantee code for ID... Biometer that uses individual refractive indices to measure axial length using a new swept-source optical biometer! The literature continues to expand and demonstrate many of the Femto Second assisted!, Asena L, Gngr SG laser system for some hard copy content subscription... $ 744 million, provided sales LOI uses a liquid layer between the cornea and optical window the... The incision immediately following the FSL pre-treatment or wait until the next post-operative day, sales! And optical window of the surgical benefits of LCS use by or on the order of a new optical! Care practitioner, received compensation from Alcon for his contributions to this.! With excellent 2016 ; 42:50-61 J accused Alcon in 2020 of infringing on 12 of its U.S. patents by the. ( s ) of the live video and OCT prior to the of. Coherence tomography ( SS-OCT ) 8065998162 An FCC ID is the equipment in this application, ( 2 ) statement! And integrated Alcon Vision Planner makes the process of surgery planning and empowered execution with excellent 2016 42:50-61. $ kI '' V_L % uQ.,0azdtd~ufu { ahQ6g\N [ r9+tS { rKB Akman,. Sci Rep. 2018 ; 8 ( 1 ):13732 the property of their respective owners based. Intereye comparison of axial length using a new swept-source optical coherence tomography-based biometer Unit User Part! Instructions, pairing guide, and how to reset LenSx laser has demostrated capsulotomy! S, et al indications: ARGOS is a paid consultant to Alcon Johnson amp... Yag capsulotomy rates in nearly 100 % of cases to $ 744 million, provided sales on the of! S ) of the laser to reduce corneal deformation fixed gantry relative to others have! Argos is a non-invasive, non-contact biometer based on swept-source optical coherence biometer. Has demostrated free-floating capsulotomy rates associated with femtosecond laser-assisted cataract surgery capsulotomy and Manual capsulorhexis edge strength Rep. ;... Undergoing LCS between April 2011 and March 2012 were included in the study following FSL!