Wood Optic Diffusion

⚠️ Moderate Risk

FEI: 3003191457 • Hosingen • LUXEMBOURG

FEI

FEI Number

3003191457

📍

Location

Hosingen

🇱🇺

Country

LUXEMBOURG

🏢

Address

Op Der Hei 11 A, , Hosingen, , Luxembourg

Moderate Risk

FDA Import Risk Assessment

29.5

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

9/5/2013

Latest Refusal

1/29/2004

Earliest Refusal

Score Breakdown

Violation Severity

38.5×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

13.5×10%

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

Violation Summary

34110×

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).

2352×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

2371×

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
9/5/2013	86HQZFRAME, SPECTACLE	235NOT IMPACT	Division of Northern Border Imports (DNBI)
9/5/2013	86HQZFRAME, SPECTACLE	235NOT IMPACT	Division of Northern Border Imports (DNBI)
6/3/2005	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	237NO PMA	Cincinnati District Office (CIN-DO)
7/22/2004	86HPAFRAME, TRIAL, OPHTHALMIC	341REGISTERED	Cincinnati District Office (CIN-DO)
7/22/2004	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	341REGISTERED	Cincinnati District Office (CIN-DO)
6/24/2004	86HPAFRAME, TRIAL, OPHTHALMIC	341REGISTERED	New York District Office (NYK-DO)
6/24/2004	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	341REGISTERED	New York District Office (NYK-DO)
6/18/2004	86HQZFRAME, SPECTACLE	341REGISTERED	Division of Southeast Imports (DSEI)
6/18/2004	86LPMLENSES, SOFT CONTACT, EXTENDED WEAR	341REGISTERED	Division of Southeast Imports (DSEI)
6/18/2004	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	341REGISTERED	Division of Southeast Imports (DSEI)
6/15/2004	86HPAFRAME, TRIAL, OPHTHALMIC	341REGISTERED	New York District Office (NYK-DO)
6/15/2004	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	341REGISTERED	New York District Office (NYK-DO)
1/29/2004	86HPAFRAME, TRIAL, OPHTHALMIC	341REGISTERED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Wood Optic Diffusion's FDA import refusal history?

Wood Optic Diffusion (FEI: 3003191457) has 13 FDA import refusal record(s) in our database, spanning from 1/29/2004 to 9/5/2013.

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. Wood Optic Diffusion's FEI number is 3003191457.

What types of violations has Wood Optic Diffusion received?

Wood Optic Diffusion has been cited for 3 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 Wood Optic Diffusion come from?

All FDA import refusal data for Wood Optic Diffusion 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.