🇨🇦 CorNeat KPro
Hazard/Reason: 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.
This page links to official sources. Verify model/lot/batch details in the official notice.