CanadaCorNeat KPro ocular implant (model/catalogue ITA 359439) by Corneat Vision Ltd. is affected. It was recalled after cumulative clinical trial data showed progressive conjunctival retraction (sometimes causing partial device exposure), difficulties maintaining a complete ocular seal that compromise the implant’s function, and a potentially increased risk of intraocular infection. Contact the manufacturer for additional information.
What's being recalled
Companies: Corneat Vision Ltd., 4 Hasheizaf St., Raanana, Israel, 4366411.
How to identify it
Affected products: CorNeat KPro; Lot or serial number: Not applicable.; Model or catalogue number: ITA 359439
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)