If an agent has signed this application on behalf of the applicant, a written letter of Filkorn et al. h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. 0000093732 00000 n Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. Were committed to providing service and repair information in accordance with EU guidelines. Trademarks are the property of their respective owners. Does this application include a request for confidentiality for any portion(s) of the data 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. 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. I am equally certain the growing body of literature confirms this belief. hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. precision at every step. Select below for other countries. 2019;19:1-13. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. The surgical correction of astigmatism is challenging. Intraoperative Uses Corneal Incisions Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. There was also a decrease in central endothelial cell loss.10 A study by Mayer showed significantly less endothelial cell loss with LenSxLaser cases compared to manual phacoemulsification. J Refract Surg. The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. The LenSx Laser offers the benefit of a gurney rather than a fixed bed. J Refract Surg. Request Sample. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa V|{OiFM#;cRImrUZ}"P. &GCt"rH!kjAlO (`Bj`fHu*])5ED1*{jW1jr2/9*pv_NZ$wQDue_6 x2 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. Europe / Middle East / Africa 64 39 for possession or distribution of a controlled substance. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. Further, the mean absolute error (MAE), a measure of predictability, was lower in the LenSx Laser group. Colombia The Patient Interface is intended for single use, only. (U.S. CODE, TITLE 47, SECTION 503). 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 endstream endobj 139 0 obj <. Ali MH, et al. Kohnen T, Mathys L, Petermann K, et al. Cataract will develop completely & cause further reduction in vision. Is there a KDB inquiry associated with this application? Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? South Korea 2019:1-8. 1. CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE South Korea J Korean Ophthalmol Soc. Manuals. 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. Show all Leica Laboratory Equipment manuals. 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. Capsulotomy specified in this application, (2) compliance statement labeling pursuant to the <2 minutes total time for patients under suction in cataract procedures, Superior endothelial cell retention at 1 and 3 months, Improved central corneal thickness at Day 1 for quieter eyes, Faster rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage, * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx, In a retrospective chart review, a greater proportion of eyes treated with LenSx, * Retrospective chart review of 225 patients for LenSx, Complete efficiency, precision, and confidence in the anterior segment. 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). In accepting a Grant of Equipment Authorization as a result of the representations made in this Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. Nagy Z. 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. Show Description +. United Kingdom - English, Americas Only these optical components can be cleaned: reflecto Brazil In addition to the growing body of literature that suggests LCS has certain advantages over manual techniques, several published studies highlight important differences among the commercially available laser platforms. The PI design is a critical differentiating factor in the various platforms. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements IdeaPad 3 Series Manual. 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. International Journal of Open Access Ophthalmology. 15. With VERION Digital Marker LenSx (DML) integration, surgeons will be able to: The Vision Planner sends the surgical plan to the DMM, eliminating transcription errors and allowing surgeons to precisely execute their plan with image-guided precision. 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. 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. Wang L, Cao D, Weikert MP, Koch DD. * Trademarks are the property of their respective owners. Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. ISO 5-8. Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. VERION Reference Unit User Manual, Part I. CAS Iberia Team. I confirm that: 0000009390 00000 n `eoo (B?A Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. Argentina Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. Chen X, et al. South Korea Purpose . Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. John Davidson, MD, is a paid consultant to Alcon. 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. Ecuador 10. * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). 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. User Manual. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. 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. Nikon Digital Camera Lens User Manual. Design: Prospective, interventional case series. John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. Legion Y520 Tower Series Quick Start Guide. Nikon Micro-Nikkor Camera Lens User Manual. 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. 0 Site for International Healthcare Professionals only. 0000001076 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 2017;43:16 21. Posted: 12/18/2018. 91 0 obj <> endobj LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. Tamaoki A, Kojima T, Hasegawa A, et al. 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. 2002 ES 300 Navigation system. 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). Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. Alcon sponsored the publication of this promotional piece. 2002 RX 300 Navigation system. 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. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). Rayon / Hemp. Spain Value in Health. Intervention: Femtosecond LCS. Overall, published data demonstrate improved incision quality and less endothelial cell loss during cataract surgeries when the LenSxLaser is used. Aperio ImageScope DX. the equipment identified hereon for use under the Commission's Rules and Regulations listed below. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. Bring proven precision and safety to every cataract procedure with the LenSx. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. Brazil 2015;41(5):1109-1110. 0000008360 00000 n - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. s364wxKcTkV3PcJd. 0000039391 00000 n Hong Kong 0000005519 00000 n E: doctorjohn@johndavidsonmd.com. Knife-Cut. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Mastropasqua L, Toto L, Mastropasqua A, et al. VERION Digital Marker User Manual. Request Quote. 4 - Contraindicaciones. Solomon has been ranked among the top 1% of ophthalmologists in the United States (U.S. News \u0026 World Report). Through continuous innovation, the LenSx Laser with ASCEND Technology sets the standard at the cornea, capsule and lens, optimizing cataract refractive procedures and consistently hitting refractive targets for the widest range of patients. The Patient Interface is intended for single use only. IOL alignment with the visual axis is important to achieve the targeted refractive outcome. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. Chan T, et al. 0000010625 00000 n AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. These letters are chosen by the applicant. In a retrospective chart review study, Vasavada et al. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. Alcon Data on File 2019, report # SD-18-0001-670-01. 2019. 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By three ways i am a licensed Healthcare Professional cataract refractive Suite allows you to complete... No fixed bed required of literature confirms this belief a retrospective cohort study from outpatient. Cataract will develop completely & amp ; cause further reduction in Vision set the grant of application! The United States ( U.S. News \u0026 World Report ) CAS Iberia Team shown!