# K233876: Unity VCS (8065000296); Unity CS (8065000297)

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Jun 21, 2024 after 197 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933880 (1994). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141065: Constellation Vision System, Alcon Research, Ltd. (2014) Summary page 6.
- K062624: Next Generation Laser, Alcon Laboratories (2007) Summary page 6.
- K161794: CENTURION Vision System (Active SentryTM), Alcon Research, Ltd. (2017) Summary page 6.

## Recalls of this device
- Aug 5, 2025 · Class II · Z-0304-2026: Due to incomplete seals in the pouch which provide the sterile barrier.
- Aug 5, 2025 · Class II · Z-0305-2026: Due to incomplete seals in the pouch which provide the sterile barrier.

## Indications for use
UNITY VCS The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. UNITY CS The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

Source page: https://510kreport.com/device/K233876
Methodology: https://510kreport.com/methodology