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Ellex Tango Reflex and Ultra Q Reflex devices — recall 64040

Health Canada — Medical Devices · Canada · 2022-04-04 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64040
Date of alert
2022-04-04
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Ophthalmology
Product type
Medical devices
Reported risk: Posterior membranectomy as originally approved by Health Canada was with respect to 'dissection of pupillary membranes' and does not include vitreous membranes/ opacities. Ellex Tango Reflex and Ultra Q Reflex devices were advised by Health Canada as being marketed with the incorrect claim for vitreolysis under the approved indication of posterior membranectomy until the last few months, when Health Canada notified Ellex/Clarion of the incorrect interpretation. Recall start date: Mar 16, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ellex-tango-reflex-and-ultra-q

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