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Centurion Vision System

by Alcon Laboratories, Inc.

510(k) K121555

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121555↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK121555 Date21 Dec 2012ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2407-2023 FDA Class II initiated 28 Jun 2023
    • Ongoing Z-2410-2023 FDA Class II initiated 28 Jun 2023

    Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

    • Terminated Z-2081-2016 FDA Class II initiated 24 May 2016

    The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.

    • Terminated Z-1940-2016 FDA Class II initiated 28 Apr 2016

    Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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 Centurion Vision System is a phacofragmentation device designed for ophthalmic surgical procedures. It employs advanced technology to facilitate cataract removal and intraocular lens implantation by emulsifying and aspirating the lens material through ultrasonic fragmentation.

This system is intended for use in operating rooms by trained ophthalmic surgeons. It is supplied as a reusable medical device, with specific models listed under FDA 510(k) clearance (K121555) and MDR authorisation. The device operates under Class II regulatory classification and is not MRI-safe. Storage and maintenance follow manufacturer guidelines to ensure sterility and functionality for repeated surgical use.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

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.

  • Is the Centurion Vision System designed for single-use or repeated surgical procedures, and how should it be maintained between uses?

    The Centurion Vision System is a reusable medical device intended for repeated use in operating rooms by trained ophthalmic surgeons. To ensure functionality and sterility between procedures, it must be cleaned, disinfected, and maintained according to the manufacturer’s guidelines, as outlined in Alcon Laboratories’ instructions. Proper maintenance is critical to preserve performance and compliance with regulatory standards.

  • What types of cataract surgeries is the Centurion Vision System specifically intended to assist with?

    The Centurion Vision System is designed for phacofragmentation during cataract removal and intraocular lens (IOL) implantation procedures. It uses ultrasonic technology to emulsify and aspirate lens material, facilitating precise surgical outcomes in standard cataract surgeries performed by ophthalmic surgeons.

  • Are there multiple models of the Centurion Vision System, and how do I identify the correct one for my practice?

    Yes, the Centurion Vision System includes multiple models, each cleared under FDA 510(k) (e.g., K121555) and MDR authorization. The listed FEI numbers (e.g., 1000120314, 3006695864) correspond to specific product variants. Your practice should verify compatibility with your surgical needs and consult Alcon Laboratories’ documentation or support team to confirm the correct model for your procedures.

  • Can the Centurion Vision System be used in environments where MRI scans are performed nearby, and why?

    No, the Centurion Vision System is not MRI-safe. This means it should not be used in or near MRI environments due to potential interference or safety risks from magnetic fields, as explicitly noted in the device’s regulatory documentation.

  • How should the Centurion Vision System be stored to ensure it remains functional and sterile for reuse?

    The device must be stored following Alcon Laboratories’ guidelines to maintain sterility and functionality. This typically includes cleaning, disinfection, and proper packaging after each use, as well as storage in a clean, dry environment away from direct sunlight or extreme temperatures. Adherence to these protocols is essential for compliance and performance.