UNITY VCS - Unity Vcs (8065000296)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• 2 recalls, same reason

  • Ongoing Z-0305-2026 FDA Class II ·initiated 5 Aug 2025
  • Ongoing Z-0304-2026 FDA Class II ·initiated 5 Aug 2025

  Due to incomplete seals in the pouch which provide the sterile barrier.

Trade Name

Unity

Generic Name

Vitrectomy system micro-cutting unit

Device Name

Vitrectomy Probes

Model / Ref / Catalog

8065753174, 00380657531745

Primary DI / UDI-DI

00380657531745

Basic UDI-DI

038065GMN000073H6

510(k) Number

K233876 ↗

FDA Product Code

HQC 510(k)

MLZ GUDID

EMDN Code

Z1212020785 Phaco-vitrectomy instruments - consumables

GMDN Term

Vitrectomy system micro-cutting unit

Models / Variants

Unity Vcs (8065000296)

Unity Cs (8065000297)

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 886.4670 510(k)

886.4150 GUDID

EU market of registration

Belgium

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Clareon, Panoptix, AutonoMe

  Class IIb

  CE/MDD

• Clareon

  Class IIb

  CE/MDR G70 020895 0412 Withdrawn Valid to Dec 2029

• PMMA IOL - Posterior Chamber

  Class IIb

  CE/MDD

• AcrySof

  Class IIb

  CE/MDR G70 020895 0397 Active Valid to Aug 2028

• Systane

  Class IIb

  CE/MDR

• AcrySof IQ Vivity

  Class IIb

  CE/MDR G70 020895 0397 Active Valid to Aug 2028

See all devices from Alcon Laboratories, Inc. →

• What are the key differences between the Unity VCS and Unity CS systems in cataract surgery?

  The Unity VCS and Unity CS are both phacofragmentation systems for cataract removal, but they differ in their core technology. The Unity VCS uses laser-based fragmentation, which provides precise, energy-controlled emulsification of the lens. In contrast, the Unity CS relies on traditional ultrasonic phacoemulsification, a well-established method for breaking down the cataract. Both systems are designed for sterile operating room use and are reusable, but the VCS’s laser capability offers an alternative approach for surgeons who prefer laser-assisted techniques.

• Are these devices single-use or reusable, and what does that mean for my practice’s workflow?

  The Unity VCS and Unity CS systems are reusable, meaning they are designed for repeated use after proper cleaning, disinfection, and maintenance. This makes them cost-effective for high-volume practices, as they eliminate the need for disposable alternatives. However, reuse requires adherence to strict sterilization protocols to ensure patient safety and device performance. Your practice will need to integrate these systems into your existing reprocessing workflow.

• What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?

  Both the Unity VCS and Unity CS have undergone FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation) requirements, confirming their substantial equivalence to predicate devices. This means they meet U.S. and EU safety and performance standards for phacofragmentation systems. Clinicians can rely on these clearances as evidence of rigorous evaluation, though local regulations (e.g., hospital purchasing policies or country-specific requirements) may still apply before use.

• How are these systems supplied, and do they require any special handling or storage conditions?

  While the exact packaging details aren’t specified, as reusable Class II devices, the Unity VCS and Unity CS are likely supplied in sterile or clean, non-sterile packaging for initial use or reprocessing. Since they’re reusable, proper storage involves keeping them in a clean, dry environment (e.g., dedicated carts or cabinets) to prevent contamination between uses. Sterilization (e.g., autoclave or chemical sterilization) will be required before each procedure, following manufacturer guidelines to maintain functionality and safety.