Meibomian Gland Evaluator (Single)

About the Product

The Meibomian Gland Evaluator is a hand held, non powered ophthalmic instrument, model MGE-1001, catalog number 300001. It is supplied non sterile, it is reusable and it is a prescription device.

This is a practice instrument rather than a consumer product, used at the slit lamp during a routine eye examination. It gives the examiner a standardized way to apply a consistent, repeatable pressure to the outer skin of the lower eyelid while the lid margin is viewed through a slit lamp biomicroscope, in place of pressing with a finger or a cotton bud. It is supplied as a single instrument and is cleaned and reused between patients.

Specifications

Care and Cleaning

Disinfect the instrument with alcohol after each use and between patients.

Warnings

Do not depress the shaft to the endpoint of the spring. Do not apply any additional force after the shaft has been depressed approximately 6 mm.

Familiarity with use of a slit lamp biomicroscope is required to use Meibomian Gland Evaluator for assessment.

Unlikely but possible complications:

• Skin abrasion (e.g., from a rough surface on the device)
• Eye abrasion (e.g., from improper contact of the instrument with the eye)
• Infection of the skin or eye (e.g., from improper or lack of disinfection after use)
• Allergic or toxic reaction (e.g., from exposure to any residue on device)

Regulatory

Class I device, prescription use, exempt from 510(k) premarket notification. Product code HOE, ophthalmic caliper, under 21 CFR 886.4350, manual ophthalmic surgical instrument. Listed with FDA by Johnson & Johnson Surgical Vision, Inc.

Labeled Indications for Use:

The Meibomian Gland Evaluator is a hand held instrument used by a physician to evaluate Meibomian gland secretions in adult patients during a routine eye examination.