# K203060: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Mar 12, 2021 after 155 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844373 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151636: AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control, Abbott Medical Optics, Inc. (2015) Summary page 5.
- K160236: Dual Pump Pack, Abbott Medical Optics, Inc. (2016) Summary page 5.

## Recalls of this device
- May 30, 2023 · Class II · Z-2247-2023: Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum deliv
- Dec 7, 2022 · Class II · Z-1005-2023: Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsif
- Sep 1, 2022 · Class II · Z-0086-2023: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

## Indications for use
The VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements. The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.

Source page: https://510kreport.com/device/K203060
Methodology: https://510kreport.com/methodology