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Constellation Vision System

by Alcon Manufacturing, Ltd.

510(k) K101285

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK101285 Date12 Nov 2010ClearedStatusActive

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0099-2024 FDA Class II initiated 18 Aug 2023

    Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

    • Terminated Z-1794-2020 FDA Class II initiated 25 Jul 2018

    There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.

  • 2 recalls, same reason

    • Terminated Z-0778-2018 FDA Class II initiated 12 Jan 2018
    • Terminated Z-0779-2018 FDA Class II initiated 12 Jan 2018

    Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.

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  • Withdrawn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, 19 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 Constellation Vision System is a vitrectomy platform designed for intraocular surgical procedures. It employs phacofragmentation technology to assist in cataract and vitreoretinal surgeries, facilitating precise tissue removal and manipulation within the eye.

This device is intended for use in ophthalmic settings and is supplied as a reusable medical instrument. It is classified as a Class II device under FDA regulations and has received FDA 510K clearance as substantially equivalent to predicate devices. The system includes multiple model variants, as indicated by the associated registration numbers, and is regulated under FDA regulation number 886.4670.

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