Product Wiki · Recalls · Health Canada — Medical Devices

Meibox Ophthalmic Camera (2019-10-07) — recall 59862

Health Canada — Medical Devices · Canada · 2019-11-01 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59862
Date of alert
2019-11-01
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/meibox-ophthalmic-camera-2019-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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