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Ciba Vision Corporation

United StatesFDA applicant, unverified FDA

Devices
62
Registrations
FDA
FDA recalls
20

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Ciba Vision Corporation makes

The company manufactures single-use and reusable soft contact lenses, including daily-wear spherical, toric, and multifocal designs, as well as contact lens care solutions for cleaning, disinfecting, and wetting. Products include specific lens formulations like nelfilcon A, tefilcon, and lotrafilcon B, alongside multipurpose and specialized cleaning solutions. Additional offerings include contact lens cases and lens comfort drops.

The portfolio includes devices classified as Class I, Class II, Class III, and unclassified (U) under FDA regulations, with some products requiring 510(k) clearance and others a Premarket Approval (PMA). These devices are listed in the FDA’s 510(k) and PMA registries. The company is based in the United States.

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

Catalogue62

Newest first, rows 1-50 of 62

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Rows 1-50 of 62

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FDA recalls20

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

FDA recall records list 20 recalls initiated by Ciba Vision Corporation, the earliest on 2002-11-12 and the most recent on 2010-04-27. By recorded status: 20 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, electrical or power 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.

Showing the 10 most recent of 20 recalls.

  • 2010

    • 27 Apr 2010 Z-1706-2010 Unclassified (pre-2012) Terminated The lenses inside the package do not match the prescription information for power labeled on the primary package. Distribution: Nationwide Distribution -- AZ, AL, CA, FL, GA, IA, IL, MA, MO, NC, NJ, NY, OH, OR, PA TN, VA and WI. Submission number: P010019S011

  • 2007

    • 30 Apr 2007 Z-0793-2007 Unclassified (pre-2012) Terminated Base curve of the lenses do not meet specification. Distribution: Nationwide. Submission number: P820086
    • 11 Jan 2007 Z-0427-2007 Unclassified (pre-2012) Terminated Reduced Ion Permeability Distribution: Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany Submission number: K033919

  • 2006

    • 13 Sep 2006 Z-0018-07 Unclassified (pre-2012) Terminated Out of specification lens curve Distribution: Worldwide-U.S., Canada, Australia and Barbados.
    • 13 Sep 2006 Z-0019-07 Unclassified (pre-2012) Terminated Out of specification lens curve Distribution: Worldwide-U.S., Canada, Australia and Barbados.
    • 13 Sep 2006 Z-0020-07 Unclassified (pre-2012) Terminated Out of specification lens curve Distribution: Worldwide-U.S., Canada, Australia and Barbados.
    • 25 Jul 2006 Z-1402-06 Unclassified (pre-2012) Terminated Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) . Distribution: Nationwide including the states of CA, HI, IL, MA, MI, NE, NJ, NY, OH, TX, UT, VA, WA. Submission number: K050065

  • 2005

    • 2 Nov 2005 Z-0182-06 Unclassified (pre-2012) Terminated Lack of assurance of sterility at the time of manufacture. Distribution: Nationwide, Canada, Germany, Benelux, and the UK Submission number: K013204
    • 21 Apr 2005 Z-0847-05 Unclassified (pre-2012) Terminated The actual power of the lenses may be different from what is indicated on the package labeling. Distribution: Nationwide, Europe

  • 2004

    • 27 Sep 2004 Z-0028-05 Unclassified (pre-2012) Terminated Stability tests at 24 months revealed failing results for disinfection efficacy. Distribution: Nationwide, Canada, Latin America, Europe, Thailand, South Africa and Asia. Submission number: K031522
Show all 20 recalls

  • 2004

    • 11 Mar 2004 Z-0740-04 Unclassified (pre-2012) Terminated The lens inside the package does not match the prescription information labeled on the primary package. Distribution: Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
    • 11 Mar 2004 Z-0741-04 Unclassified (pre-2012) Terminated The lens inside the package does not match the prescription information labeled on the primary package. Distribution: Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
    • 11 Mar 2004 Z-0742-04 Unclassified (pre-2012) Terminated The lens inside the package does not match the prescription information labeled on the primary package. Distribution: Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
    • 11 Mar 2004 Z-0743-04 Unclassified (pre-2012) Terminated The lens inside the package does not match the prescription information labeled on the primary package. Distribution: Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.

  • 2003

    • 13 Aug 2003 Z-1234-03 Unclassified (pre-2012) Terminated Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date. Distribution: CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI Submission number: P900029
    • 6 May 2003 Z-0827-03 Unclassified (pre-2012) Terminated Lenses may be labeled with the incorrect axis. Distribution: The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe. Submission number: K963487
    • 17 Mar 2003 Z-0703-03 Unclassified (pre-2012) Terminated The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints. Distribution: Nationwide, Canada and Puerto Rico. Submission number: K003071
    • 17 Jan 2003 Z-0787-03 Unclassified (pre-2012) Terminated FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton. Distribution: The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR,…
      Full distribution text The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.
      Submission number: P830037

  • 2002

    • 16 Dec 2002 Z-0405-03 Unclassified (pre-2012) Terminated Mislabeling Distribution: 01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved. CIBA Vision…
      Full distribution text 01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved. CIBA Vision Canada, Ontario, Canada.
      Submission number: P830037
    • 12 Nov 2002 Z-0342-03 Unclassified (pre-2012) Terminated Lenses were labeled with the wrong prescription. Distribution: U.S. accounts: CA, GA, IL, MN, NJ, TX, VA. Foreign Distributors: Austria, Belgium, Denmark, Finland, France, Germany,…
      Full distribution text U.S. accounts: CA, GA, IL, MN, NJ, TX, VA. Foreign Distributors: Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Luxembourg, Moracco, Netherlands, Norway, Portugal, Spain, South Africa, Sweden, Switzerland and the United Arab Emirates. No government accounts involved.
      Submission number: P820086

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Ciba Vision GmbH GROSSWALLSTADT Bavaria · DE FEI 3002806704

Frequently asked questions

How many devices does Ciba Vision Corporation have in the registry?

The registry currently lists 62 devices for Ciba Vision Corporation. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ciba Vision Corporation's devices?

Among its 50 most recently registered devices, Ciba Vision Corporation has devices listed in FDA 510(k) (43 devices) and FDA PMA (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ciba Vision Corporation's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Ciba Vision Corporation's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Ciba Vision Corporation?

FDA recall records list 20 recalls initiated by Ciba Vision Corporation, the most recent initiated on 27 Apr 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 Ciba Vision Corporation in the registry?

The most recently registered devices listed for Ciba Vision Corporation include FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS, AQUIFY LENS COMFORT DROPS, GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR and AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION.

Which FDA establishments are linked to Ciba Vision Corporation?

1 FDA establishment is linked to Ciba Vision Corporation in the registry; they are listed on the company page.

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