Skip to content

Vistakon

Country not established

Devices
5
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Vistakon makes

Vistakon manufactures soft (hydrophilic) contact lenses, including daily-wear and tinted variants with UV-blocking properties. Their portfolio includes lenses made from materials such as etafilcon A, senofilcon A, hefilcon C, and methafilcon A, designed for vision correction and cosmetic enhancement.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Vistakon, the earliest on 2009-04-20 and the most recent on 2010-07-16. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 16 Jul 2010 Z-2445-2010 Unclassified (pre-2012) Terminated ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper f Distribution: Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada,…
      Full distribution text Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.

  • 2009

    • 20 Apr 2009 Z-2012-2009 Unclassified (pre-2012) Terminated Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling. Distribution: Nationwide.

Frequently asked questions

How many devices does Vistakon have in the registry?

The registry currently lists 5 devices for Vistakon. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vistakon's devices?

Among its 5 most recently registered devices, Vistakon has devices listed in FDA 510(k) (5 devices).

What risk classes do Vistakon's devices fall under?

Among its 5 most recently registered devices, the classes recorded for Vistakon's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Vistakon?

FDA recall records list 2 recalls initiated by Vistakon, the most recent initiated on 16 Jul 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Vistakon in the registry?

The most recently registered devices listed for Vistakon include ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC, VISTAKON (SENOFILCON A) SOFT CONTACT LENS, ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER and VISTAKON (HEFILCON C) CONTACT LENSES.

Generated automatically from registry data and not verified by a human reviewer.