CorNeat KPro
Brand(s)
Last updated
Summary
Product
CorNeat KPro
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
CorNeat KPro |
Not applicable. |
ITA 359439 |
Issue
The recall is being carried out because cumulative global clinical data from the ongoing clinical investigation revealed emerging safety concerns. These concerns include:
- progressive conjunctival retraction, which in some cases led to partial exposure of the device.
- difficulties maintaining a complete ocular seal, compromising the intended function of the implant.
- a potentially increased risk of intraocular infection, associated with these complications.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies
Corneat Vision Ltd.
4 Hasheizaf St., Raanana, Israel, 4366411
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82215
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