• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    K-Tube Technologies

    MW Life Sciences

    Spectrum Plastics Group

    Qosina Corp.

    Unicep
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Creganna Medical, part of TE Connectivity

    Spectrum Plastics Group

    Concise Engineering

    Element

    FUTEK Advanced Sensor Technology Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Approves First IOL to Enable Refractive Correction After Cataract Surgery

    FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device.

    FDA Approves First IOL to Enable Refractive Correction After Cataract Surgery
    Related CONTENT
    • CMS Expedites Breakthrough Device Access; Industry Applauds
    • Preparing Your Design Controls for FDA Approval
    • The Big Challenges of Medical Device Miniaturization
    • How Design Controls Can Prevent Medical Device Recalls
    • Novocure Earns CE Mark for NovoTTF-100L System
    U.S. Food and Drug Administration11.27.17
    The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
     
    Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses. Refractive error, which is caused when the artificial lens does not focus properly, causes blurred vision.
     
    “Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”
     
    The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.
     
    A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75 percent also had a reduction in astigmatism.
     
    The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases.
     
    The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.
     
    The FDA approved the Vision Light Adjustable Lens and the Light Delivery Device to RxSight Inc.
    Related Searches
    • patient
    • power
    • protection
    • u.s. food and drug administration
    Related Knowledge Center
    • Surgical
    Suggested For You
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    The Big Challenges of Medical Device Miniaturization The Big Challenges of Medical Device Miniaturization
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    Novocure Earns CE Mark for NovoTTF-100L System Novocure Earns CE Mark for NovoTTF-100L System
    HeartHero Inc. Awarded ISO 13485 Certification HeartHero Inc. Awarded ISO 13485 Certification
    The Heart of the Matter: Trends in Cardiology The Heart of the Matter: Trends in Cardiology
    My 2020 Holiday Wish List My 2020 Holiday Wish List
    FDA Approves Boston Scientific FDA Approves Boston Scientific's Ranger Drug-Coated Balloon
    First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status
    Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials
    Nines Receives FDA Approval Enabling Democratized Access to AI-Enabled Radiology Nines Receives FDA Approval Enabling Democratized Access to AI-Enabled Radiology
    Employee Feedback Should Be Part of a Product Safety Plan Employee Feedback Should Be Part of a Product Safety Plan
    Medtech Mettle: The 2017 Year in Review Medtech Mettle: The 2017 Year in Review
    FDA Commissioner Declares New Steps to Advance Medical Device Innovation FDA Commissioner Declares New Steps to Advance Medical Device Innovation

    Related Breaking News

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21

    • Packaging & Sterilization | Surgical
      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      Olympus Releases ScopeLocker Endoscope Storage Cabinet

      HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.
      Olympus 01.06.21


    • Surgical
      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

      Treats patients with necrotic tissue resulting from complications of acute pancreatitis.
      U.S. Food and Drug Administration 01.04.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21

    • Surgical
      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      Clinical Trial to Study Impact of ActivePure Technology on Surgical Site Infections

      The study will use 50 noncardiac, adult operating rooms at Cleveland Clinic.
      Aerus Medical 12.14.20


    • Cardiovascular | Surgical
      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Foldax Earns FDA Approval for Biopolymer Mitral Heart Valve Study

      Valve designs intended to resist calcification, withstand stresses and strains without failure.
      Business Wire 12.14.20

    • Surgical
      Aspen Surgical Acquires Protek Medical Products

      Aspen Surgical Acquires Protek Medical Products

      Acquisition bolsters Aspen’s portfolio of patient and staff safety products.
      Business Wire 11.24.20

    • Surgical
      FDA Clears Penumbra

      FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Embolism

      Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots.
      Business Wire 11.20.20


    • Diagnostics | Surgical
      Allotrope Medical

      Allotrope Medical's StimSite Wins FDA Nod

      Lets surgeons use existing surgical instruments to help locate, identify ureters using electrical stimulation.
      PR Newswire 11.18.20

    • Cardiovascular | Surgical
      Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

      Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

      Voluntary recall is related solely to the delivery system.
      PR Newswire 11.17.20

    • Surgical
      Entrepix Medical Launches Surgical Blade Technology Focused on Patient Healing

      Entrepix Medical Launches Surgical Blade Technology Focused on Patient Healing

      Planatome technology applyies a patented, nano-polishing process that eliminates the manufacturing defects found on all standard scalpels.
      Globe Newswire 11.13.20


    • 3D/Additive Manufacturing | Surgical
      Biodegradable 3D Printed Stents Treat Esophageal Inflammation

      Biodegradable 3D Printed Stents Treat Esophageal Inflammation

      Stent with esophageal-derived bioink helps treat radiation esophagitis.
      POSTECH 11.12.20

    • Surgical
      OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device

      OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device

      The company's FGS imaging technology illuminates critical anatomy in real-time during surgery to optimize precision.
      Business Wire 11.12.20

    • Machining & Laser Processing | Surgical
      Resonetics Acquires Hutchinson Technology

      Resonetics Acquires Hutchinson Technology's Medical Business

      Adds photochemical machining, metal forming, and sensor technology for minimally invasive surgical devices.
      PR Newswire 11.03.20


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Moon Surgical Expands Leadership Team
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    P&G, L'Oréal & Amorepacific Make News at CES
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login