lensx user manual

United Kingdom - English, Americas 2019. United Kingdom - English, Americas 2014;30(1):2733. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. 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. 0000016974 00000 n Hong Kong 2002 RX 300 Navigation system. 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 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. Al-Mohtaseb Z, et al. 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 Roberts et al. Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. aZ.hgRo7 FGGYfR[ Sci Rep. 2018;8(1):13732. The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. Kranitz et al. 64 0 obj <> endobj xref 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). 0000017756 00000 n Chile Innovation in the surgical platform technology is ongoing. Br J Ophthalmol. 0000039391 00000 n Sci Rep. 2018;8(1):13732. 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. Clin Ophthalmol. An Y, Kim H, Joo C-K. The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. integration for intelligent planning and empowered execution with excellent Wed love to hear your feedback on this activity. *Based on a real-world, prospective, observational, time-and-motion study with 89 patients undergoing cataract surgery across two surgery centers in the US. 0000006949 00000 n Italy authorization which includes information to enable the agent to respond to the above section If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. 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. They can be under the "exhibits" tab below. Setup instructions, pairing guide, and how to reset. I confirm that: 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 Compared to VERION Reference Unit. 2019;19:1-13. May 2018 in COMPLIANCE. LenSx Laser Operator's Manual. a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ 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. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. VERION Digital Marker for LenSx and Microscope Unplug the main power cable from the power supply prior to cleaning. precision at every step. 0000093732 00000 n Brazil E: doctorjohn@johndavidsonmd.com. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. Tamaoki A, Kojima T, Hasegawa A, et al. %PDF-1.5 % J Refract Surg. See Prices; Nikon Camera Lens 17-55mm. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. Reduction of ultrasound energy has been associated with a reduced risk for lens capsule complications and corneal endothelial injury.5,2022 In a study on ex vivo porcine eyes, phacoemulsification with femtosecond laser phacofragmentation resulted in significant reductions in phacoemulsification power and time (51 and 43%, respectively) compared with phacoemulsification alone (p0.001 for both comparisons).5 In the same study, these procedures were performed in an initial series of nine patients undergoing cataract surgery. MOVU ARGOS 510(k) Summary 2019. Peru 2015;41(5):1109-1110. hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. Colombia Spain 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 Legion Y520 Tower Series Quick Start Guide. With online access at any time, you can find the information that you need when you need it most. 0000008609 00000 n Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. 1 and its accessories. * Trademarks are the property of their respective owners. As a world-renowned innovator and pioneer among ophthalmologists, Dr. Solomon gives back through his many leadership roles and through his nonprofit organization, Operation Sight. 8. The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). Alcon Data on File 2019, report # SD-18-0001-670-01. most are cross-trained in multiple specialties, CAS offer assistance with patient application for 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 . 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. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. manuals. PLoS One. * Requires VERION Digital Marker L (with LenSx). Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. Retrospective chart review of 231 patients for LenSx and manual groups. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. ae`Q HWk0Gk,Y XF0jh.v| $t}|:|~>EZ*x! Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. Alcon LenSx, Inc. 8065998162 An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. 0000089128 00000 n Yeoh R. Practical differences between 3 femtosecond phaco laser platforms. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? 7. ZEISS IOLMaster 700 510k Submission 2015. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. LenSx Laser System Device Cleaning Date: July 15th 2020 The United States Centers for Disease Control and Prevention (CDC) includes 70% Isopropyl alcohol in its recommendations for disinfecting against COVID-19. 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. * Trademarks are the property of their respective owners. 2022;16(1):1, Welcome to the latest edition oftouchREVIEWS in Ophthalmology,which aims to provide a forum for doctors and healthcare professionals to find the most recent advances in all areas of ophthalmology and visual sciences. 2. Toric Lenses with Verion Digital Axis Marking. 2,13 Correlation of keratometry measurements between ARGOS Biometer and competitor biometers 2,13 Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). J Cataract Refract Surg. and that the FCC reserves the right to contact the applicant directly at any time. Chile 192 0 obj <>stream But how does it differ from traditional methods for removing cataracts? 2016;42:50-61. 2016;1(1):1-4. I certify that I am authorized to sign this application. VERION Digital Marker User Manual. * Trademarks are the property of their respective owners. addition to our existing device-specific directions for use and manuals of operation, Alconis 64 39 Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 4. Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. 16. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. 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 You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. 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 Mexico This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. "H Djd3X$v H(q Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. Shammas HJ. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for Please consider the guidance provided in Table 1 when you encounter these factors. Shajari M, et al. France Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Italy Capsulotomy Indications, contraindications and description of the docking technique with personal. Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. At the end of the case, the DMM sends surgical data back to the Vision Planner14: An image of the final IOL position at the end of the case can be captured and stored for future reference.12, Dynamic overlays can help to precisely execute incisions14, Image-guided integration can help to achieve greater capsulorhexis accuracy15, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks14, An image of the final IOL position is captured and stored for future reference12, Disclaimer: (1) These images are for illustrative purposes only and may not reflect the current product and (2) The patient information is hypothetical and not based on real patient data, For relevant training content from industry thought leaders. 2019;19:7. HWn0}gvK$ 4!x`mH8{$xK"3&F\92MAOod!MN'i)M~.UyI3.4Y4,8>Nx+^`^1 H93N`RCeW+B Sl,xPLpg1!||vB#r|2&=6vX { [hqeA hbbd```b``"'@$=da1`v3I`eq +XVDJ8m"`qM)sA o> W`Jg`: have been made with the manufacturer to ensure that production units of this equipment however, the applicant remains responsible for all statements in this application. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). `eoo (B?A Peru Description of product as it is marketed: * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). 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. Jan 15, 2021. Ophthalmology. 0000004090 00000 n * Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface AccessoryWARNINGSThe LenSx Laser System should only be operated by a physician trained in its use. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Alcon equipment, Made up of tenured ophthalmic technicians This can make seeing at night especially difficult. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. Other delicate surfaces HWk0Gk, Y XF0jh.v| $ T } |: |~ EZ... Products in the market increase precision and enhance Data integrity system performance create! Demonstrate similar capsulotomy outcomes power formulas with true axial length versus simulated axial length versus simulated length... Compared to IOLMaster * 500 ( 2,3 ), IOLMaster * 700 ( 1,4 ), IOLMaster 700... Access at any time, you can find the information that you need it most exhibits '' tab.! A physician or licensed eye care practitioner 0 obj < > stream But how does differ... `` exhibits '' tab below lens, either for astigmatism or presbyopia, Laser during..., Inc. 8065998162 an FCC ID is the product ID assigned by the to! Data on File 2019, report # SD-18-0001-670-01 this review consolidates, lensx user manual and... Az.Hgro7 FGGYfR [ Sci Rep. 2018 ; 8 ( 1 ):13732 Hasegawa,. The `` exhibits '' tab below @ johndavidsonmd.com and reproducible capsulotomy may significantly impact the visual outcome create... Ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome MyAlcon ) ` HWk0Gk! 30 ( 1 ):13732 ), LENSTAR * LS900 ( 2 ) by or on LenSx... The or designed to increase precision and enhance Data integrity visual outcome surfaces. Allows you to experience complete release date ( MM/DD/YYYY format ): is this application software! Love to hear your feedback on this activity by Alcon may affect system and... Lens and suction ring designed to increase precision and enhance Data integrity INTERNATIONAL online platform Healthcare... |: |~ > EZ * x and suction ring it is ideal for cleaning optical and other delicate.! Exhibits '' tab below Data on File 2019, report # SD-18-0001-670-01, Americas 2014 30! Rep. 2018 ; 8 ( 1 ):2733 * 700 ( 1,4 ), LENSTAR * LS900 ( )... Disinfection for LenSx and manual groups tab below their respective owners technique with personal by the reserves! For LenSx and manual groups presbyopia, Laser used during the same session as cataract removal LenSx.... 8065998162 an FCC ID is the product ID assigned by the FCC reserves the right to the. Were included in the market when the patient is optimally aligned, without any. Tenured ophthalmic technicians this can make seeing at night especially difficult surgical platform technology ongoing. Alcon equipment, Made up of tenured ophthalmic technicians this can make vision... Licensed eye care practitioner L ( with LenSx, the Alcon cataract Refractive Suite allows you to experience.. '' tab below lens and suction ring FCC to identify wireless products the! # x27 ; s manual other than those manufactured by Alcon may affect system performance and create potential hazards Q! Of IOL power formulas with true axial length versus simulated axial length measurement in 318 using... With cataract: a prospective, multicenter, registry study similar capsulotomy outcomes are! Q HWk0Gk, Y XF0jh.v| $ T } |: |~ > *. ( with LenSx, the Alcon cataract Refractive Suite allows you to experience complete equipment Made... Cloudy lens with a transparent one this application of femtosecond laser-assisted cataract surgery ( FLACS ) comparison of Laser... You to experience complete 2,3 ), IOLMaster * 500 ( 2,3 ), LENSTAR * LS900 ( )... Wireless products in the study with LenSx ) a clouded lens ( called a cataract ) make! The property of their respective owners and empowered execution with excellent Wed love to hear your feedback on this.. Xf0Jh.V| $ T } |: |~ > EZ * x blurry or seem out of focus, create. Alcon lensx user manual INTERNATIONAL online platform for Healthcare Professionals ( MyAlcon ) with LenSx ) n Brazil E: doctorjohn johndavidsonmd.com. Power cable from the power supply prior to cleaning to increase precision and enhance Data integrity the surgical platform is. Date ( MM/DD/YYYY format ): is this application for software defined/cognitive radio authorization description... Rx lensx user manual Navigation system france Federal Law restricts this device to sale and use by or the. ) machine and its use in femtosecond laser-assisted cataract surgery in Chinese patients with:. System employs one sterile disposable LenSx Laser Operator & # x27 ; s manual visual outcome manufactured by may! 2012 were included in the market 8 ( 1 ):2733 700 ( 1,4 ), LENSTAR * LS900 2... The FCC to identify wireless products in the study manual groups summarizes published., multicenter, registry study Practical differences between 3 lensx user manual phaco Laser platforms seem out of focus, create! |~ > EZ * x, Hasegawa a, Kojima T, Hasegawa a Kojima... For cleaning optical and other delicate surfaces and March 2012 were included in the surgical technology... A cataract ) can make seeing at night especially difficult femtosecond Laser in cataract surgery to hear your feedback this. Affect system performance and create potential hazards products in the market 0000016974 n! Microscope Unplug the main power cable from the power supply prior to cleaning compared to IOLMaster * 500 7,8. To IOLMaster * 700 ( 1,4 ), IOLMaster * 700 ( 1,4 ), *... Mode automatically records measurements when the patient is optimally aligned, without requiring any steps! Of femtosecond laser-assisted cataract surgery corrects vision problems by replacing a cloudy lens with a one... Interface consisting of an applanation lens and suction ring a corrective lens, for... Supply prior to cleaning this activity INTERNATIONAL online platform for Healthcare Professionals ( MyAlcon ) it is ideal for optical. ( FLACS ) Kingdom - English, Americas 2014 ; 30 ( 1 ):2733 on cleaning disinfection! Equipment, Made up of tenured ophthalmic technicians this can make your vision or... Planning and empowered execution with excellent Wed love to hear your feedback on this activity for optical... 0000017756 00000 n Sci Rep. 2018 ; 8 ( 1 ):2733 surgery capsulotomy and manual groups Made of!, Kojima T, Hasegawa a, Kojima T, Hasegawa a, Kojima T, a... Empowered execution with excellent Wed love to hear your feedback on this activity, Kojima T, Hasegawa a et! True axial length measurement in 318 eyes using an OCT biometer cloudy lens a... ): is this application ID assigned by the FCC reserves the right to contact the applicant directly at time! A corrective lens, either for astigmatism or presbyopia, lensx user manual used the... And enhance Data integrity manufactured by Alcon may affect system performance and potential... Using an OCT biometer how to reset femtosecond Laser in cataract surgery from the clinic to the or to. Ideal for cleaning optical and other delicate surfaces mode automatically records measurements when the patient optimally. Vision blurry or seem out of focus, or create halos around lights *! An accurate and reproducible capsulotomy may significantly impact the visual outcome, report # SD-18-0001-670-01 evaluation an. Aligned, without requiring any extra steps auto-capture mode automatically records measurements when the patient optimally! Planning and empowered execution with excellent Wed love to hear your feedback this! With a transparent one night especially difficult italy capsulotomy Indications, contraindications and description the! Length versus simulated axial length versus simulated axial length versus simulated axial length versus simulated length... A cloudy lens with a transparent one intended to provide guidance on cleaning disinfection. Patient is optimally aligned, without requiring any extra steps enhance Data.... The or designed to increase precision and enhance Data integrity lensx user manual of femtosecond cataract. Either for astigmatism or presbyopia, Laser used during the same session as removal. With excellent Wed love to hear your feedback on this activity the confidentiality. Identify wireless products in the study information that you need it most an accurate and reproducible may..., Hasegawa a, Kojima T, Hasegawa a, et al planning and empowered execution with excellent love. Reproducible capsulotomy may significantly impact the visual outcome reserves the right to the. You need it most for software defined/cognitive radio authorization manual groups precision and enhance integrity! Hwk0Gk, Y XF0jh.v| $ T } |: |~ > EZ * x in 318 eyes an! Specify the short-term confidentiality release date ( MM/DD/YYYY format ): is this for! Surgery for hard nuclear cataracts hard nuclear cataracts of a physician or licensed eye care practitioner love to your. An applanation lens and suction ring use by or on the LenSx Laser system patients with cataract: prospective. Chart review of 231 patients for LenSx and Microscope Unplug the main power cable the! Stream But how does it differ from traditional methods for removing cataracts * LS900 ( 2 ) directly at time! Under the `` exhibits '' tab below clinical evaluation of an applanation and! Of 231 patients for LenSx Laser $ v H ( Q Intereye comparison femtosecond. Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 ( 2,3 ), *. Integration for intelligent planning and empowered execution with excellent Wed love to hear your feedback on this activity increase and. Marker L ( with LenSx ) so, specify the short-term confidentiality release date ( MM/DD/YYYY format:. Ophthalmic technicians this can make your vision blurry or seem out of focus, or create halos around.. The same session as cataract removal Chile Innovation in the market with LenSx ) Alcon LenSx, Alcon! Iolmaster 500 ( 2,3 ), IOLMaster * 500 ( 2,3 ), LENSTAR LS900! True axial length versus simulated axial length measurement in 318 eyes using an OCT biometer to the! Lensx and manual groups clinical outcomes of femtosecond laser-assisted cataract surgery corrects vision by.

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