510(k) Report

FDA applicant

Ciba Vision Corporation

Duluth, GA56 decisions1979–20146 recalls

FDA records 56 decisions for Ciba Vision Corporation (Duluth, GA) from 1979 to 2014: 44 510(k) clearances and 12 original PMA approvals. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPN (Accessories, Soft Lens Products). Its devices cite 41 predicates, 30 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Ciba Vision Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 22009: 12012: 12013: 12014: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ciba Vision Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ciba Vision Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear21decisions
  • LPNAccessories, Soft Lens Products14decisions
  • MVNLens, Contact, (Disposable)6decisions
  • MRCProducts, Contact Lens Care, Rigid Gas Permeable5decisions
  • LRXCase, Contact Lens2decisions
  • HNOKeratome, Ac-Powered2decisions

Also: LPM (2), HQD (1), LYL (1), LOH (1), MWL (1).

Whose devices does it build on?

Its devices cite 41 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 105 times; 30 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsCiba Vision Corporation · 200410cite it
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 20089cite it
  • K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 19966cite it
  • K022687Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 20026cite it
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal ToricCiba Vision Corporation · 20126cite it
  • K003345Aosept Plus Cleaning and Disinfecting SolutionCiba Vision Corporation · 20016cite it

What has FDA decided for it lately?

  • K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
  • K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus MultifocalCiba Vision Corporation · 2013
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal ToricCiba Vision Corporation · 2012
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
  • K072777Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2008
  • K062262Ciba Vision (Sifilcon a) Spherical, Toric, Multifocal and Multifocal Toric DesignsCiba Vision Corporation · 2006
  • K041820Solo-Care Aqua Antimicrobial Lens CaseCiba Vision Corporation · 2005

All 56 as Ciba Vision Corporation →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K033919OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is…Jan 11, 2007
  • K050065Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA VisionJul 25, 2006
  • K013204AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact…Nov 2, 2005
  • K031522SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label)…Sep 27, 2004
  • K963487Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic)…May 6, 2003
  • K003071Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single…Mar 17, 2003

Other applicant names beginning “Ciba”

FDA records each applicant name separately; these may or may not be the same firm.

Ciba Corning Diagnostics Corp. 125Ciba Vision Care 4Ciba-Geigy Corp. 2Ciba Vision Johns Creek Mfg. 1