CARL ZEISS VISION SUNLENS ASIA P
⚠️ Moderate Risk
FEI: 3013174220 • Shatin, Hong Kong • CHINA
FEI Number
3013174220
Location
Shatin, Hong Kong
Country
CHINAAddress
Unit 1315, 13F Delta Hou, Shatin, Hong Kong, China
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) | |
| 2/18/2025 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is CARL ZEISS VISION SUNLENS ASIA P's FDA import refusal history?
CARL ZEISS VISION SUNLENS ASIA P (FEI: 3013174220) has 7 FDA import refusal record(s) in our database, spanning from 2/18/2025 to 2/18/2025.
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. CARL ZEISS VISION SUNLENS ASIA P's FEI number is 3013174220.
What types of violations has CARL ZEISS VISION SUNLENS ASIA P received?
CARL ZEISS VISION SUNLENS ASIA P 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 CARL ZEISS VISION SUNLENS ASIA P come from?
All FDA import refusal data for CARL ZEISS VISION SUNLENS ASIA P 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.