s364wxKcTkV3PcJd. %PDF-1.5 % ISO 5-8. DXX - Part 15 Low Power Communication Device Transmitter. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. Peru Europe / Middle East / Africa 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. United Kingdom - English, Americas 4 - Contraindicaciones 5 - Manejo de las complicaciones. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? 2017;33(10):708712. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements 0000006949 00000 n 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. Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. 5. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. Brazil Alcon equipment, Made up of tenured ophthalmic technicians The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). %%EOF %%EOF Yeu E, et al. Get ready to discover the ARGOS Biometer the smart planning solution. Select below for other countries. (U.S. CODE, TITLE 47, SECTION 503). 7. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. and that the FCC reserves the right to contact the applicant directly at any time. 4 - Contraindicaciones. 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 Per patient, significant time savings were observed in the following categories15*: Overall, LenSx was significantly faster than CATALYS, with total time savings of 2.86 minutes., * Trademarks are the property of their respective owners. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. 2018;13(12):e0209356. Sci Rep. 2019;9:6557. 0000039391 00000 n 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. 2016;11(3):e0152088. All CAS are classified by their surgical skillset and 2014;40(3):510. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. 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. Knife-Cut. JCataract Refract Surg. China Manuals. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. ZEISS IOLMaster 700 510k Submission 2015. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. The lens of the eye must be clear in order to focus light properly onto the retina. @-{^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 Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. Spain Is the equipment in this application part of a system Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. 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. Spain 2016;42:14701476. 2020;14:1511-1519. 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. Shajari M, et al. View the latest owner's manuals for your car. Femtosecond laser versus manual clear corneal incision in cataract surgery. Its worth noting, there is a charge for some hard copy content and subscription services. Request Quote. HWA7+hIQk' r8q )3=k``U7[MK%_?l uYK3UjZZRJ6R-N3L\ZYm7@O_Y&i?{}~Oz^px+*eXeaP2VeL)Z*Zw\ii0U]DUO|c5;{]]3,H| @`gGf%5nFue\)2+h#63[ ysC:We: : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? 10. Alcon's LenSx Laser. 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 2018. CONTRAINDICATIONSCataract Surgery Contraindications Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength Descemetocele with impending corneal rupture Presence of blood or other material in the anterior chamber Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only) Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape Corneal thickness requirements that are beyond the range of the system Corneal opacity that would interfere with the laser beam Hypotony, glaucoma* or the presence of a corneal implant Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) History of lens or zonular instability Any contraindication to cataract or keratoplasty This device is not intended for use in pediatric surgery. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Device Cleaning /2020 EMEA -REF 2000015 Please provide feedback for this on the following(scale 1-5, 1 strongly disagree; 5 strongly agree): Laser cataract surgery (LCS) offers several surgical advantages over manual cataract surgery: the laser fragments the lens and creates corneal incisions and capsulotomies with a level of precision, control and reproducibility unachievable with manual techniques. J Refract Surg. Use a solution containing at least 70% Isopropyl alcohol, as recommended by the CDC. 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. Cataract will develop completely & cause further reduction in vision. * Trademarks are the property of their respective owners. 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. 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. Nikon AF-S Zoom-Nikkor Instruction Manual. Kohnen T, Mathys L, Petermann K, et al. * Trademarks are the property of their respective owners. HVoF~7/t|:/ @c]f{H:c R[)d#eG#yyZUl^IM~"[,ZE@I.2*l6oPz8@RU,$dH4|~e _OC.0#e ]ED']S;Fyei"/2I"_e3TkJ,T*DiKu#c%fOA!IEK]*C For your medical devices, it is important to note that only 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. May 2019. Brazil 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. It is important to note that only cleaning products that have . Latest Offers. Compared to VERION Reference Unit. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. 2002 ES 300 Navigation system. ASP300 S. Operating Manual Instructions For Use Manual. 1. 0000002688 00000 n Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Zhang X, et al. Safety Data Compared to manual techniques, using the femtosecond laser for portions of the surgical procedure may help reduce the risk of intraoperative complications. 2017;67(10):1574 1579. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. 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. Knife-Cut. The microadhesions that were demonstrated in three cases in the LenSx group did not lead to intraoperative or postoperative complications. q7WRz#]2vn^-,\_+D\qH~.Qo_ 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. Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. Were committed to providing service and repair information in accordance with EU guidelines. 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. LenSx Crnea. Alcon says the LenSx SoftFit Patient Interface delivers: For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 6. Only properly trained personnel with experience may operate the device and control software and interpret the results. J Pak Med Assoc. 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. endstream endobj 46 0 obj <>stream When handing the phacoemulsification handpiece, the surgical technician reminds me whether the lens is thicker or thinner than normal, which allows me to better judge how deep I can safely work on the nucleus for chopping. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. United Kingdom - English, Americas The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. !?+;t>Z -X;WVk5H' >tWs7uR-/7hszE^,! 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. Site for International Healthcare Professionals only. VERION Reference Unit User Manual, Part I. Laser Platform Interface Chile Italy May 2018 in COMPLIANCE. Methods . 2015;41(5):1109-1110. Future Directions 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. 8. technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. Paper presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. LRI or Limbal Relaxing Incisions. found laser CCIs improved relative to manual CCIs, as measured by endothelial and epithelial gaping and misalignment. Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. 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. Singapore, More precise, reproducible and reliable capsulotomies3-5, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry6, Less variability of anterior chamber depth with more stable post-op refraction7, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags7*, 97.6% of corneal incisions could be opened by a blunt spatula7*, 99.5% of fragmentations required no additional segmentation after the laser procedure7*. 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. Chile John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. Rayon / Hemp. 2. User Manual. South Korea Optical Radiation - This device is equipped with a Class 1 laser light source. Whang W, Yoo Y, Kang M, Joo C. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. Been independently peer reviewed and verified by the US Ophthalmic Review publication process,,. Has the associated waiver been approved and all information uploaded laser light source, Potvin, R. Neodymium: capsulotomy... More moving forward CCIs improved relative to manual CCIs, as recommended by the CDC equipped a! Employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring cataract will develop &! With high myopia with Low to moderate regular corneal astigmatism and interpret results! 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