Ciba Vision Corporation: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Ciba Vision Corporation” (first 1994, latest 2014), plus 12 PMA decisions, across 11 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Alcon, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 155 |
| 2013 | 1 | 57 |
| 2014 | 1 | 104 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 21 | 14 |
| LPN | Accessories, Soft Lens Products | 14 | 14 |
| MVN | Lens, Contact, (Disposable) | 6 | 6 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 5 | 5 |
| HNO | Keratome, Ac-Powered | 2 | 2 |
| LPM | Lenses, Soft Contact, Extended Wear | 2 | 0 |
| LRX | Case, Contact Lens | 2 | 2 |
| HQD | Lens, Contact (Other Material) - Daily | 1 | 0 |
| LOH | System, Identification, Contact Lens | 1 | 0 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (56)
Most recent Ciba Vision Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | 2014-01-29 | 104 |
| K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | 2013-02-21 | 57 |
| K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | 2012-03-30 | 155 |
| K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | 2009-04-14 | 165 |
| K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES | LPL | 2008-02-28 | 80 |
| K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | 2008-01-24 | 118 |
| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | LPL | 2006-11-14 | 102 |
| K041820 | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE | LRX | 2005-09-09 | 430 |
| K050250 | AQUIFY MULTIPURPOSE SOLUTION | LPN | 2005-08-10 | 188 |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | MVN | 2005-05-27 | 135 |
34 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890029 | PMA | EXCELENS (ATLAFILCON A) CONTACT LENS | 1989-12-28 |
| P890012 | PMA | SIGNATURE CONTACT LENS | 1989-09-15 |
| P890020 | PMA | FLUOROCON TM-60 | 1989-06-23 |
| P850033 | PMA | SCANLENS (SCAFILCON A CONTACT LENS) | 1986-11-28 |
| P850072 | PMA | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS | 1986-07-17 |
Recalls
20 product recalls in 15 recall events; 0 initiated in the last five years. Most recent: 2010-04-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ciba Vision Corporation is the lead sponsor of 52 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01629706: Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers (Completed, started 2012-09)
- NCT01614678: A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens (Completed, started 2012-06)
- NCT01461811: Prospective Study of an Investigational Toric Soft Contact Lens (Completed, started 2011-12)
- NCT01473160: Daily Disposable Contact Lens Tear Film Study (Completed, started 2011-11)
- NCT01446835: Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect (Completed, started 2011-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ciba Corning Diagnostics Corp. (125 510(k)s)
- Ciba Vision Care (2 510(k)s)
- Ciba Vision Johns Creek Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ciba Vision Corporation?
FDA lists 44 510(k) clearances under the applicant name “Ciba Vision Corporation” (first 1994, latest 2014), plus 12 PMA decisions, across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ciba Vision Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ciba Vision Corporation is 84 days.
Which FDA product codes appear under Ciba Vision Corporation?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 21); LPN (Accessories, Soft Lens Products, 14); MVN (Lens, Contact, (Disposable), 6).
Next steps
- See all 44 Ciba Vision Corporation clearances with predicates and recalls
- Run predicate analysis for product code LPL, Ciba Vision Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.