Labtician Ophthalmics Inc.

⚠️ Moderate Risk

FEI: 3002807445 • Oakville, Ontario • CANADA

FEI

FEI Number

3002807445

📍

Location

Oakville, Ontario

🇨🇦

Country

CANADA

🏢

Address

2140 Winston Park Dr Unit 6, , Oakville, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

46.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/13/2013

Latest Refusal

8/5/2011

Earliest Refusal

Score Breakdown

Violation Severity

40.4×40%

Refusal Volume

66.4×30%

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

11860×

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).

34160×

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).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	79LROKIT, SURGICAL - GENERAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86MMLWEIGHTS, EYELID, EXTERNAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
12/13/2013	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
8/5/2011	86HQJIMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHODS)	75UNAPPROVED	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Labtician Ophthalmics Inc.'s FDA import refusal history?

Labtician Ophthalmics Inc. (FEI: 3002807445) has 61 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 12/13/2013.

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. Labtician Ophthalmics Inc.'s FEI number is 3002807445.

What types of violations has Labtician Ophthalmics Inc. received?

Labtician Ophthalmics Inc. 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 Labtician Ophthalmics Inc. come from?

All FDA import refusal data for Labtician Ophthalmics Inc. 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.