Ciba Vision GmbH
⚠️ High Risk
FEI: 3002806704 • Groswallstadt, Bavaria • GERMANY
FEI Number
3002806704
Location
Groswallstadt, Bavaria
Country
GERMANYAddress
Industriering 1, , Groswallstadt, Bavaria, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2025 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 9/22/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 9/25/2019 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of Southeast Imports (DSEI) | |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 3/21/2018 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Northern Border Imports (DNBI) |
| 1/5/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Florida District Office (FLA-DO) | |
| 11/23/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 10/16/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 9/3/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 3/6/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/7/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 86NICLENS, CONTACT, FOR READING DISCOMFORT | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 1/22/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 12/13/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 11/14/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 10/29/2013 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | New Orleans District Office (NOL-DO) | |
| 10/18/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 10/18/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 10/18/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 10/18/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 10/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 10/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 2/4/2010 | 86MVNLENS, CONTACT (DISPOSABLE) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ciba Vision GmbH's FDA import refusal history?
Ciba Vision GmbH (FEI: 3002806704) has 63 FDA import refusal record(s) in our database, spanning from 2/4/2010 to 8/1/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Ciba Vision GmbH's FEI number is 3002806704.
What types of violations has Ciba Vision GmbH received?
Ciba Vision GmbH has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Ciba Vision GmbH come from?
All FDA import refusal data for Ciba Vision GmbH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.