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Ellex tango reflex and ultra q reflex devices

Official notice

4 Apr 2022

Last checked

4 Apr 2022

Medium riskHealth Canada

An official Health Canada notice concerns Ellex tango reflex and ultra q reflex devices. 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 Published 2022-04-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64040

Official notice

2022-04-04

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64040

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Affected products

Product 1

Affected Products - Ellex Ultra Q, Lot or Serial Number - Not applicable., Model or catalog number - LQP3106-U ULTRA

Product 2

Affected Products - Ellex Ultra Q-R, Lot or Serial Number - Not applicable., Model or catalog number - LQP106-U ULTRAQ REFLEX

Product 3

Affected Products - Ellex Tango-R, Lot or Serial Number - Not applicable., Model or catalog number - LT5106-T TANGO REFLEX

Product 4

Affected Products - Ellex Tango, Lot or Serial Number - Not applicable., Model or catalog number - LT5106-T TANGO

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Ellex Medical, Ellex Tango Reflex And Ultra Q Reflex Devices.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64040

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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