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Health Canada Medical devices

Ellex Tango Reflex and Ultra Q Reflex devices

Issued April 4, 2022
Issue
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
Hazard description
Revised instructions for use
Product
Product name
Ellex Tango Reflex and Ultra Q Reflex devices
Reference
ID
RA-64040