Sclera Contact Lenses

⚠️ High Risk

FEI: 3010944248 • Cockfosterscockfosters • UNITED KINGDOM

FEI

FEI Number

3010944248

📍

Location

Cockfosterscockfosters

🇬🇧

Country

UNITED KINGDOM

🏢

Address

56 Games Road The Gatewaycockfosters, , Cockfosterscockfosters, , United Kingdom

High Risk

FDA Import Risk Assessment

50.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

11/30/2018

Latest Refusal

11/10/2015

Earliest Refusal

Score Breakdown

Violation Severity

56.8×40%

Refusal Volume

59.7×30%

Recency

0.0×20%

Frequency

100.0×10%

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

50840×

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.

11839×

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).

328039×

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.

Refusal History

Date	Product	Violations	Division
11/30/2018	86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY	508NO 510(K)	Division of Southeast Imports (DSEI)
11/26/2018	86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/30/2017	86LPLLENSES, SOFT CONTACT, DAILY WEAR	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/25/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/23/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/20/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
11/10/2015	86MVNLENS, CONTACT (DISPOSABLE)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sclera Contact Lenses's FDA import refusal history?

Sclera Contact Lenses (FEI: 3010944248) has 40 FDA import refusal record(s) in our database, spanning from 11/10/2015 to 11/30/2018.

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. Sclera Contact Lenses's FEI number is 3010944248.

What types of violations has Sclera Contact Lenses received?

Sclera Contact Lenses 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 Sclera Contact Lenses come from?

All FDA import refusal data for Sclera Contact Lenses 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.