Visiontech Medical Optics Ltda
⚠️ Moderate Risk
FEI: 3003433668 • Belo • BRAZIL
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2010 | 86MSSFOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/1/2010 | 86KYBLENS, GUIDE, INTRAOCULAR | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/6/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Visiontech Medical Optics Ltda's FDA import refusal history?
Visiontech Medical Optics Ltda (FEI: 3003433668) has 3 FDA import refusal record(s) in our database, spanning from 2/6/2002 to 10/1/2010.
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. Visiontech Medical Optics Ltda's FEI number is 3003433668.
What types of violations has Visiontech Medical Optics Ltda received?
Visiontech Medical Optics Ltda has been cited for 2 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 Visiontech Medical Optics Ltda come from?
All FDA import refusal data for Visiontech Medical Optics Ltda 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.