Recall Monitor
Health Products

CorNeat KPro

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: CorNeat KPro
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
CorNeat KProNot 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.

Get told about the next health product recall.
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