Meibox Ophthalmic Camera (2019-10-07)

Starting date:

October 7, 2019

Posting date:

November 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71451

Last updated: 2019-11-01

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  Reason
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  Affected products

Affected Products

Meibox Ophthalmic Camera

Reason

The camera which is used as an "educational tool" by optometrists, in educating patients of Meibomian Gland Dysfunction (MGD) was flagged (by Health Canada) for not having a medical device licence.  They indicated that the device is a class II medical device under rule 10(1). Follow up emails concluded that although the device does not diagnose or directly treat the patient - it is used to encourage patients to stay compliant with treatment and therefore requires a class II medical device licence.

Affected products