FDA Clears Centricity Vision's IOL positioning system

ZEPTOLink is being introduced this weekend at the American Society of Cataract and Refractive Surgery Annual Meeting in San Diego. (Image Courtesy of Adobe Stock)

Centricity Vision Inc. this week announced it has received 510(k) clearance from the FDA for its ZEPTOLink IOL Positioning System.

According to the company, the platform integrates the ZEPTO precision pulse capsulotomy technology with any phacoemulsification (phaco) system to streamline cataract surgery.

Centricity Vision noted ZEPTO creates an instantaneous capsulotomy with 360-degree IOL overlap for optimal lens positioning and improved outcomes.

Moreover, the company noted 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.

The company noted 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:

• 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. The company noted that 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 said in a news release. "We believe this streamlined surgical solution will help drive the future of automated refractive cataract surgery."