FDA Clears Centricity Vision's ZEPTOLink IOL Positioning System

New Platform Integrates with all Phacoemulsification Systems; First Look Offered at ASCRS Conference

CARLSBAD, Calif., May 3, 2023 /PRNewswire/ -- Centricity Vision Inc., a global ophthalmic technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new ZEPTOLinktm IOL Positioning System. The new platform seamlessly integrates the clinically proven ZEPTO precision pulse capsulotomy technology with any phacoemulsification (phaco) system to streamline cataract surgery.

ZEPTO is the first and only device that creates an instantaneous capsulotomy with consistent, 360-degree intraocular lens (IOL) overlap for optimal lens positioning and improved outcomes. The ZEPTOLink platform integrates with any phaco system, saving time and space in the operating room. The technology delivers the same strong, consistent, centered capsulotomy while providing surgeons with complete control via the phaco foot pedal. ZEPTOLink will be introduced at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in San Diego, with demonstrations performed at the Centricity Vision booth #710.  

ZEPTOLink uses suction and irrigation provided by the phaco system, enabling surgeons to fully control the ZEPTO handpiece apposition, suction, energy delivery, and release using the phaco foot pedal. Key features include:

• Seamless integration with any phacoemulsification system
• Small ergonomic console that attaches to any phaco system
• Modern touchscreen display with voice-supported functions
• Dedicated ZEPTOLink handpiece for efficient set-up, priming, and operation by a single person all within the sterile field
• Clinically proven ZEPTO technology for precise, consistent, and centered capsulotomies with 360-degree IOL overlap

Following ASCRS, Centricity Vision is planning a phased approach for the U.S. market roll-out of ZEPTOLink, with a broader commercial launch later this year.

"As a current user, I value the safety, precision, and consistency of a ZEPTO capsulotomy. Now with the phaco integration, ZEPTOLink offers greater workflow efficiency than ever before," said Eric Donnenfeld, MD.

Creating a well-formed, centered capsulotomy is among the most difficult steps of cataract surgery, and it is essential for effective IOL positioning and stability. By applying 12 micro-pulses of energy in just 4 milliseconds, ZEPTOLink enables surgeons to center the capsulotomy with 360-degree IOL overlap on the patient's visual axis for improved outcomes^1-4.

"By improving IOL centration and operating room productivity, ZEPTOLink will benefit patients and practices alike," said Centricity Vision President and CEO Rob Thornhill. "We believe this streamlined surgical solution will help drive the future of automated refractive cataract surgery."

About the ZEPTO IOL Positioning System
Designed to enhance the precision and efficiency of cataract surgery, the ZEPTO IOL Positioning Systemtm is the first and only device that creates an instantaneous capsulotomy for precise, 360-degree IOL overlap and improved outcomes. ZEPTO is ideal for premium IOLs and complex cases that require enhanced precision. ZEPTO also provides significant cost and time savings with easy workflow integration and increased efficiency per case.

About Centricity Vision Inc.
Based in Carlsbad, California, Centricity Vision is a global ophthalmic technology company and developer of the U.S. and internationally approved ZEPTO IOL Positioning Systemtm. Centricity Vision's expert team is dedicated to providing advanced surgical solutions to improve long-term visual outcomes and deliver the best vision care to patients. For more information, visit Zeptozone.com, or follow Centricity Vision on LinkedIn, Facebook, and Twitter.

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References

1. Thompson V, Holladay J, Sretavan D. Use of P1-P4 Purkinje reflections as a surrogate sign for intraoperative patient fixation. J Cataract Refract Surg. 2021 Dec 1;47(12):e60-e65. doi: 10.1097/j.jcrs.0000000000000805. PMID: 34486578.
2. Singh I. For IOL placement, location is key. Ophthalmol Times. 2020;45(11):1,19.
3. Ifantides C, Lee J, Rouweyha R, VitalM, Sretavan D. Precision pulse capsulotomy: performance metrics and utility In routine and complex cases. J Cataract Refract Surg. 2020;46(11):1522-1529.
4. Gundersen K, Potvin R. Clinical results after precision pulse capsulotomy. Clin Ophthalmol. 2020;14:4533-4540.

SOURCE Centricity Vision