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

by Johnson & Johnson Surgical Vision, Inc.

510(k) K203060

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203060 Date12 Mar 2021ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2247-2023 FDA Class II initiated 30 May 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 delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

    • Ongoing Z-1005-2023 FDA Class II initiated 7 Dec 2022

    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 phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

    • Ongoing Z-0086-2023 FDA Class II initiated 1 Sep 2022

    As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VERITAS system is a phacoemulsification console designed for anterior segment cataract surgery, combining ultrasound emulsification and irrigation/aspiration to remove the eye’s natural lens. It integrates modular components, including a console, fluidics packs, handpiece, foot pedal, and remote control, to streamline surgical workflows and enhance precision during cataract extraction procedures.

This device is supplied as a reusable console with single-use fluidics packs, handpiece, foot pedal, and remote control, intended for use in sterile operating room environments. It is classified as a Class II medical device under FDA regulations (510(k) K203060) and adheres to MRI safety standards for ophthalmic surgical settings. Components are sterilized via manufacturer-provided protocols and require proper storage to maintain functionality and compliance with regulatory requirements.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the VERITAS system designed to assist with, and how does it work?

    The VERITAS system is specifically designed for anterior segment cataract surgery, where it combines ultrasound emulsification and irrigation/aspiration to remove the eye’s natural lens. It integrates modular components like the console, fluidics packs, handpiece, foot pedal, and remote control to streamline the workflow, enhancing precision during phacoemulsification—a key step in cataract extraction.

  • Are the fluidics packs, handpiece, foot pedal, and remote control reusable or single-use, and how should they be handled?

    The VERITAS system includes a reusable console paired with single-use fluidics packs, handpiece, foot pedal, and remote control. These single-use components are intended for sterile operating room environments and must be discarded after one use to maintain sterility and compliance with manufacturer-provided protocols.

  • How should the VERITAS system components be stored to ensure proper functionality and regulatory compliance?

    The VERITAS system components require proper storage to preserve functionality and meet regulatory standards. The reusable console and single-use items must be stored according to manufacturer guidelines, which likely include environmental controls (e.g., temperature, humidity) and protection from contamination to ensure sterility and performance integrity.

  • What regulatory pathway was followed for the VERITAS system, and what does this mean for its use in clinical settings?

    The VERITAS system underwent a traditional 510(k) clearance process through the FDA, classified as substantially equivalent (SESE) under the Ophthalmic advisory committee (OP). This means it was determined to have the same intended use and technological characteristics as a legally marketed predicate device, allowing it to be used in clinical settings for anterior segment cataract surgery as described.

  • Does the VERITAS system comply with MRI safety standards for ophthalmic surgical settings?

    Yes, the VERITAS system adheres to MRI safety standards suitable for ophthalmic surgical environments. This ensures compatibility with MRI equipment in operating rooms where both surgical procedures and imaging may occur, reducing potential interference or safety risks.