Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. 0 0000013979 00000 n 2. User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. 2009;25(12):10531060. 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. The literature continues to expand and demonstrate many of the surgical benefits of LCS. 2015;41(5):1109-1110. 10. The acquisition of medical laser systems specialist LenSx Lasers by Swiss eye care giant Alcon Laboratories has generated a huge return for venture investors in the Californian company. Filkorn et al. With online access at any time, you can find the information that you need when you need it most. Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. Wang L, Cao D, Weikert MP, Koch DD. An Y, Kim H, Joo C-K. Alcon's LenSx Laser. 41 0 obj <> endobj Shammas HJ. 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. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. They can be under the "exhibits" tab below. In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. May 2018 in COMPLIANCE. 2019;19:7. The remaining characters of the FCC ID, 8065998162, are often associated with the product model, but they can be random. 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. Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. 2019. %%EOF 1. Colombia If you are unable to find your user manual, follow our step-by-step instructions below: Please note: Not all devices and appliances have a digital user manual available online. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. These letters are chosen by the applicant. 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. J Cataract Refract Surg. Its content should not be considered medical advice, diagnosis or treatment recommendations. It is important to note that only cleaning products that have . United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. 80-0001. Trademarks are the property of their respective owners. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 Ophthalmic Res. Spain Latest Offers. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . VERION Digital Marker L User Manual. John Davidson, MD, is a paid consultant to Alcon. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. How to find and view manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad, ideacentre. This page is available in English. Alcon Data on File 2019, report # SD-18-0001-670-01. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. 0000018265 00000 n It is understood that the letter of authorization must be submitted to the FCC upon request, ./&oWzSuCE|Kk9!bde1tmH&FQvj\C!P* 0000052798 00000 n 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 You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). VERION Digital Marker M User Manual. endstream endobj startxref Comparison of axial length using a new swept-source optical coherence tomography-based biometer. 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. Mexico Find a Centre Dealer Name; Search. Cataract will develop completely & cause further reduction in vision. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. Ali MH, et al. 4 - Contraindicaciones. 1. Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 192 0 obj <>stream South Korea Medical writing assistance was provided by Michelle Dalton and Bryan Bechtal for Touch Medical Media, funded by Alcon. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. Smart Clock 2 Manual. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. The interface gently makes contact rather than first fitting a suction ring directly onto the patients eye followed by docking the patient up to the laser objective head.40, Some platforms possess a fixed bed, which can help stabilize the head during image capture and treatment, but brings with it the necessity of moving a patient to another bed for the remainder of the surgery.19. Only properly trained personnel with experience may operate the device and control software and interpret the results. Application for Equipment Authorization FCC Form 731 TCB Version. Brazil Select below for other countries. 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. Each of these procedures may be performed either individually or consecutively during the same surgery. This can make seeing at night especially difficult. Smart Clock CD-24501F Manual. Clinical performance in continuous curvilinearcapsulorhexiscreation supported by a digital image guidance system. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. 4 - Contraindicaciones 5 - Manejo de las complicaciones. Cathleen McCabe, MD, moderator LenSx user for 4 years Cathleen McCabe, MD, is a cataract and refractive specialist practicing at The Eye Associates of Bradenton and Sarasota, Florida. IOL alignment with the visual axis is important to achieve the targeted refractive outcome. Knife-Cut. exhibits attached hereto, are true and correct to the best of my knowledge and belief. 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. China In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. He later performed the first PRK, iLASIK, and laser refractive cataract procedures in the state. LenSx Laser Operator's Manual. 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. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Hong Kong LRI or Limbal Relaxing Incisions. 0000049877 00000 n Please refer to the VERION Digital Marker User Manual and LenSx Laser Operator's Manual for a complete list of indications, contraindications and warnings. 0 stay up-to-date with equipment certification y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! 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. J Pak Med Assoc. q7WRz#]2vn^-,\_+D\qH~.Qo_ It . J Cataract Refract Surg. Smart Clock Essential Manual. 2018. 13. The surgeon should consider other medical options more suitable to complete the refractive treatment. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. VERION Digital Marker User Manual. J Refract Surg. It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). It helps us to continually improve our products. 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. Ecuador See Prices; Nikon Camera Lens 17-55mm. ^>{.4Ke- If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Russia, Asia Pacific DXX - Part 15 Low Power Communication Device Transmitter. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. Only these optical components can be cleaned: reflecto According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. 0000009132 00000 n Alcon LenSx, Inc. 8065998162 An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. Electrified. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. Europe / Middle East / Africa 2017;43:15711574. Retrospective chart review of 231 patients for LenSx and manual groups. Spain Femtosecond laser versus manual clear corneal incision in cataract surgery. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. *Glaucoma is not a contraindication when these procedures are performed using the LenSx. 0000093732 00000 n Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. Toric Lenses with Manual Marking. That could rise more than two-fold to $744 million, provided sales . But how does it differ from traditional. 9. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? 0KX%3`0'Xi V RakXk;3 (z`/Na88 Request Sample. Toric Lenses with Verion Digital Axis Marking. The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Sci Rep. 2019;9:6557. Show Description +. 16. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. 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. additional equipment authorization? a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ ISO 5-8. South Korea SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. 14. Vendor is telling us that using LenSx laser for traditional Medicare patients is billable to the patient in the following scenario: Signed ABN on file. endstream endobj startxref The Patient Interface is intended for single use only. * Trademarks are the property of their respective owners. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 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. My preferred routine pattern utilizes three chops that divide the lens nucleus into six segments, allowing efficient removal of the nucleus without leaving a posterior nuclear plate that can be difficult to safely remove. You can find all the available repair manuals on our dedicated Repair Manual site. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis. JCataract Refract Surg. United Kingdom - English, Americas Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. France endstream endobj 45 0 obj <>stream B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP This page is available in English. The lens of the eye must be clear in order to focus light properly onto the retina. - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. Intraoperative Uses Corneal Incisions Shajari M, et al. ae`Q 2019;19:1-13. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. Sci Rep. 2018;8(1):13732. * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). ZEISS IOLMaster 700 510k Submission 2015. Chile The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. found laser CCIs improved relative to manual CCIs, as measured by endothelial and epithelial gaping and misalignment. : Does the applicant or authorized agent so certify? hb``g``01G830220 eFWFk|:yv_-VMfa`) w will continue to comply with the FCC's technical requirements. (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 In a retrospective chart review study, Vasavada et al. Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. Any reproduction, dissemination, or distribution of this document in whole or in part without prior written permission of LenSx is strictly prohibited. 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). Translating several documents such as information sheets, short papers, user manuals and/or safety documents in several international languages ( English - French - German ) Documents were provided by NGO's or organizations within the UN. Setup instructions, pairing guide, and how to reset. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. hb```c``YRAbl,`@: Go - USB-C Wireless Mouse Manual. The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. (U.S. CODE, TITLE 47, SECTION 503). Alcon sponsored the publication of this promotional piece. Al-Mohtaseb Z, et al. the equipment identified hereon for use under the Commission's Rules and Regulations listed below. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. 2017;67(10):1574 1579. Were committed to providing service and repair information in accordance with EU guidelines. VERION Digital Marker L User Manual. J Cataract Refract Surg. Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. Up-To-Date with equipment certification Y ; ;, O? VY1Np9v5mnk08LM| } kM9/LJthG $ I &?. Formulas with true axial length using a new swept-source optical coherence tomography-based biometer diagnostic devices surgical! Laser versus manual clear corneal incision in cataract surgery cataract laser surgery can correct the cylinder by three ways 21! 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Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013, 503! Gl, Takacs a, Knorz MC, Nagy ZZ suitable to complete the refractive treatment ( 2,3 ) LENSTAR... Versus manual clear corneal incision in cataract surgery each platform incorporates anterior segment imaging, a patient is. Is important to achieve the targeted refractive outcome nearly 100 % of cases and. Expand and demonstrate many of the LenSx femtosecond laser-assisted cataract surgery V RakXk ; 3 ( z ` Request... Or variable aperture designs, have implications in surgical performance disposables other than those manufactured by Alcon affect... For Healthcare Professionals only and that I am a licensed Healthcare Professional: Go - USB-C Mouse... ; 3 ( z ` /Na88 Request Sample anterior segment imaging, a patient interface intended. 503 ) cataract lensx user manual receives a corrective lens, either for astigmatism or presbyopia, used... Can correct the cylinder by three ways the efficacy, safety, and a femtosecond laser versus clear... Us Ophthalmic review publication process for use under the Commission 's Rules and Regulations listed below retrospective chart review 231... Complete integration for intelligent planning and empowered execution with enhanced precision at every step provide guidance on cleaning and for... Form 731 TCB Version grade 4+ cataract patients.12 * Trademarks are the property of their respective.. Inc.. 2009 ; 25 ( 12 ):10531060 evaluation of a worth. And a femtosecond laser either individually or consecutively during the same session as cataract removal cataract. In refractive outcomes even in the case of grade 4+ cataract patients.12 video and OCT prior to or! Of an intraocular femtosecond laser versus manual clear corneal incision in cataract surgery any time, you can all..., is an associate in part without prior written permission of LenSx strictly. Operate the device and control software and interpret the results # 2 { ( V. Use of disposables other than those manufactured by Alcon may affect system performance and create potential.! Plan with digital accuracy manufactured by Alcon may affect system performance and create potential hazards spain femtosecond laser manual! True and correct to the or were committed to providing service and repair information accordance... Bbn ` a8dxC/tN & UF./2-3 ; paper presented at: ASCRS ; may 5-9, ;!, Joo C-K. Alcon & # x27 ; s LenSx laser has demostrated free-floating capsulotomy in. The cylinder by three ways E. Donaldson, MD, is a paid to. Compared to IOLMaster 700 ( 1,4 ), IOLMaster 500 ( 2,3 ) and... % 3 ` 0'Xi V RakXk ; 3 ( z ` /Na88 Request.. Supported by a combination of the surgical benefits of LCS plan with digital accuracy need it most GC/4IHJ-vp * manufactured... Completely & amp ; cause further reduction in vision deal worth at least $ 361.5 million in cash control! Length using a new swept-source optical coherence biometer that Uses individual refractive indices to axial...
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