The FDA announced 510(k) clearance for two technologies in its new UNITY surgical equipment portfolio: the UNITY Vitreoretinal Cataract System (VCS) and the UNITY Cataract System (CS).
First: Remind me what a 510(k) clearance means.
This type of FDA clearance is reserved for Class II-classified medical devices with a moderate level of associated risk attached to them that have been reviewed and registered with the agency.
As one of the most common routes for bringing a product to market, 510(k) clearance indicates that a company has proven substantial equivalence with a predicate device.
In other words: The product must be deemed comparable to another device that’s already been legally marketed by the FDA.
Now a refresher on Alcon’s surgical equipment.
Until now, the Alcon Vision Suite lineup of surgical equipment has primarily centered around clinical diagnostics and cloud-based solutions for cataract surgery.
A total of six systems offer unique diagnostic and visualization capabilities:
- CENTURION Vision System
- For cataract surgery; features ACTIVE SENTRY, a proprietary technology that reduces post-occlusion surge and maintains stability within the anterior chamber
- CONSTELLATION Vision System
- For vitreoretinal surgery (anterior and posterior segment surgeries)
- LenSx Femtosecond Laser System
- LuxOR Revalia Ophthalmic Microscope
- NGENUITY 3D Visualization System
- ARGOS Biometer
And this new UNITY brand?
This next-generation of systems incorporate both vitreoretinal and cataract surgery-based consoles:
- UNITY VCS: Indicated for use during anterior segment (phacoemulsification and cataracts removal) and posterior segment (vitreoretinal) ophthalmic surgery
- UNITY CS: Indicated for use with compatible devices during only anterior segment (phaco and cataracts removal) ophthalmic surgery
As with previous surgical equipment, both systems will be supported by Alcon’s training, product maintenance, and service teams.
How do these systems differ from the company’s current tech?
Alcon noted that the UNITY VCS and CS provide “significant workflow efficiencies” that surpass the company’s two current leading systems:
Also: These two devices (with over 28,000 currently available in the ophthalmic surgical marketplace) are expected to be upgraded to the UNITY platform over the next 10 years, according to the company.
Sounds like quite an advancement! So is there any supporting clinical data for UNITY?
Indeed there is… Alcon reported that both UNITY platforms have undergone testing during investigational advisory wet lab sessions involving 200+ surgeons from over 30 countries across the globe.
Note: Data from these sessions was not provided.
With this new clearance, “Alcon will begin a thorough program to secure real-world feedback before commercial launch in 2025,” the company stated.
Less than 6 months to go then... what about in other countries?
Additional regulatory submissions for the UNITY platforms are planned in ophthalmic surgical markets around the world—more specifically, Alcon expects to earn a CE mark for distribution in theEuropean Union (EU) by early 2025.
And lastly, what does this clearance indicate for the Alcon Vision Suite?
Expansion, to say the least.
The company plans to add on to the UNITY portfolio beyond just the VCS and CS systems over the next few years—offering ophthalmic surgeons continued advancements in the cataract and vitreoretinal surgery spaces.