View the latest owner's manuals for your car. Lensx 90 is engineered for extreme softness and for use in the cleaning of delicate lens surfaces. Mayer et al. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. 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. Site for International Healthcare Professionals only. Colombia 0000039391 00000 n %%EOF 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 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. May 2019. It is important to note that only cleaning products that have . A Pilot Study To Compare Using VERIONImaging Guided System (Alcon) To Manual Marking In Assisting LRI (Limbal RelaxationIncision) To ReduceCylinder Power In Cataract Surgery. Kohnen T, Mathys L, Petermann K, et al. John Davidson, MD, received compensation from Alcon for his contributions to this 121 0 obj <>/Filter/FlateDecode/ID[<9358EA72A4CF3F4C97265D9BE7ADE418><4C551F67350B71468EFAB08426468B96>]/Index[91 52]/Info 90 0 R/Length 135/Prev 125778/Root 92 0 R/Size 143/Type/XRef/W[1 3 1]>>stream 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 Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. 0000009390 00000 n Femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` Description of product as it is marketed: . An Y, Kim H, Joo C-K. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. VERION Reference Unit User Manual Part II. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. Kranitz et al. 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. 0000039216 00000 n Nagy Z. The Patient Interface is intended for single use only. Safety Data Compared to manual techniques, using the femtosecond laser for portions of the surgical procedure may help reduce the risk of intraoperative complications. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. * Trademarks are the property of their respective owners. 0 7. Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. 2017;43:348-352. 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). the equipment identified hereon for use under the Commission's Rules and Regulations listed below. By clicking Yes. Is the equipment in this application a composite device subject to an 0000001076 00000 n 2018. The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. 64 0 obj <> endobj xref ^>{.4Ke- 0 endstream endobj startxref Is there a KDB inquiry associated with this application? Alcon equipment, Made up of tenured ophthalmic technicians South Korea Trademarks are the property of their respective owners. 0000010600 00000 n China ARGOS Optical Biometer Important Product InformationCaution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. Were committed to providing service and repair information in accordance with EU guidelines. 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 Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). SUV. 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. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. Automobile. 0000049877 00000 n Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. 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. 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. She is a consultant to and speaker for Alcon. Lensx 90 is 100% cleanroom lens cleaning wipe & tissue. Pages: 34. J Cataract Refract Surg. Show all Leica Laboratory Equipment manuals. specified in this application, (2) compliance statement labeling pursuant to the Hong Kong Manuals. PLoS One. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. Use a solution containing at least 70% Isopropyl alcohol, as recommended by the CDC. * Retrospective chart review of 225 patients for LenSx and manual groups. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. Intraoperative Uses Corneal Incisions 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 France Authorizing an agent to sign this application, is done solely at the applicant's discretion; +*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 Find a Centre Dealer Name; Search. 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. Tamaoki A, Kojima T, Hasegawa A, et al. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 2. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. Clinical performance in continuous curvilinearcapsulorhexiscreation supported by a digital image guidance system. 0000001520 00000 n Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. 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. I am equally certain the growing body of literature confirms this belief. 2019. and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to 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. * Trademarks are the property of their respective owners. 2002 RX 300 Navigation system. Methods . It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. 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. Request Quote. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. Check if a local MyAlcon page for your country to access country product information. MOVU ARGOS 510(k) Summary 2019. 0000052912 00000 n authorization which includes information to enable the agent to respond to the above section 0000006949 00000 n 1 - Introduccin al LASIK y la ciruga corneal. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR 0000009132 00000 n (U.S. CODE, TITLE 47, SECTION 503). Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Identifying anatomic landmarks with anterior segment imaging is a critical component of LCS to ensure proper placement of the anterior capsular opening. 2017;67(10):1574 1579. United Kingdom - English, Americas 0000039322 00000 n 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 Capsulotomy and manual capsulorhexis edge strength studies, the LenSx laser Operators manual for a complete of... 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