American Optical Lens Company
⚠️ Moderate Risk
FEI: 1219337 • Southbridge, MA • UNITED STATES
FEI Number
1219337
Location
Southbridge, MA
Country
UNITED STATESAddress
50 Optical Dr Ste 200, Southbridge Business Center, Southbridge, MA, United States
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
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).
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 |
|---|---|---|---|
| 8/25/2011 | 86HKYTONOMETER, MANUAL | Detroit District Office (DET-DO) | |
| 8/25/2011 | 86HMECHAIR, OPHTHALMIC, AC-POWERED | Detroit District Office (DET-DO) | |
| 8/25/2011 | 86HMECHAIR, OPHTHALMIC, AC-POWERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is American Optical Lens Company's FDA import refusal history?
American Optical Lens Company (FEI: 1219337) has 3 FDA import refusal record(s) in our database, spanning from 8/25/2011 to 8/25/2011.
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. American Optical Lens Company's FEI number is 1219337.
What types of violations has American Optical Lens Company received?
American Optical Lens Company 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 American Optical Lens Company come from?
All FDA import refusal data for American Optical Lens Company 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.