Ellex Tango Reflex and Ultra Q Reflex devices
Brand(s)
Last updated
Summary
Product
Ellex Tango Reflex and Ultra Q Reflex devices
Issue
Medical devices - Revised instructions for use
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or Serial Number | Model or catalog number | ||
|---|---|---|---|---|
| Ellex Ultra Q | Not applicable. | LQP3106-U ULTRA | ||
| Ellex Ultra Q-R | Not applicable. | LQP106-U ULTRAQ REFLEX | ||
| Ellex Tango-R | Not applicable. | LT5106-T TANGO REFLEX | ||
| Ellex Tango | Not applicable. | LT5106-T TANGO |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies
Ellex Medical Pty Ltd
3-4 Second Avenue, Mawson Lakes, South Australia
Australia, 5095
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64040
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