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FDA approves ZEISS's VISUMAX 800 with new SMILE pro software

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3 min read

ZEISS Medical Technology (Carl Zeiss Meditic AG) has received FDA approval for the VISUMAX 800 with SMILE (small incision lenticule extraction) pro software from ZEISS, intended to surgically treat nearsightedness (with or without astigmatism).

Let’s start with the VISUMAX 800

The VISUMAX 800 is marketed as a next-generation femtosecond laser system with the most advanced, fastest laser speed compared to its predecessors.

Case in point:

With a faster laser pulse repetition rate (of 2 Hz, to be exact), the system can create a lenticule in < 10 seconds (for SMILE) and a complete flap cut in an estimated 5 seconds for Femto-LASIK.

Per the system’s brochure, the VISUMAX 800 can perform the following treatments:

  • SMILE pro (our topic of discussion)
  • Flap cut for Femto-LASIK
  • CIRCLE software for retreatment (when medically necessary)
  • Tunnel incisions for intracorneal rings (ICR)
  • Keratoplasty option for corneal transplants

Now let’s talk about the SMILE pro combo.

The addition of SMILE pro software with the VISUMAX 800 not only can provide faster treatment, but—as a result—it also has the potential to reduce stress for both patients and surgeons with enhanced digital workflows, according to ZEISS.

Plus, the duo comes with a smaller footprint (creating more clinical space) and is compatible with “a variety of patient beds.”

So what other features are included?

A key component are intelligent robotic assistant systems, designed to provide enhanced control for surgeons during procedures:

  • CentraLign assistant system
    • Computer-controlled function for easy centration. It uses pupil center and vertex position to give the surgeon full control of centration during the docking phase.
  • OcuLign system
    • Cyclotorsion alignment system features an intuitive OcuLign pattern rotation to automatically recalculate treatment patterns and counter potential cyclotorsion that may occur perioperatively.

See here (page 4) for more details.

Go on…

The system also utilizes the VISULYZE user nomogram, an all-in-one software tool designed to assist surgeons in collecting and analyze patient data plus creating and providing detailed nomograms—giving them potentially more control during surgeries.

And the significance of this?

With this laser system and SMILE pro software already adopted across the globe, this new addition to the U.S. market can help refractive surgeons’, “manage better treatment paths for patients while supporting each surgeon’s unique practice requirements for greater workflow efficiency and performance,” stated Euan S. Thomson, PhD, president of Ophthalmology Strategic Business Unit and head of the Digital Business Unit for ZEISS Medical Technology.

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