Ellex Tango Reflex and Ultra Q Reflex devices
Brand(s)
Summary
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
Ellex Medical Pty Ltd
3-4 Second Avenue, Mawson Lakes, South Australia
Australia, 5095