FDA Clears Centricity Vision's ZEPTOLink IOL Positioning System
Thursday, May 04, 2023
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 ZEPTOLink™ 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 outcomes1-4.
"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."