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Corneat kpro

Official notice

17 Jun 2026

MediumHealth Canada

An official Health Canada notice concerns Corneat kpro. 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. Published 2026-06-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82215

Official notice

2026-06-17

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.

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.

Skus

ITA 359439

Other

RA RA-82215

Model Numbers

ITA 359439

Recall Numbers

82215

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Affected products

Product 1

Lot or serial number - Not applicable., Model or catalogue number - ITA 359439

Risk / 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.

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: Corneat Vision.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82215

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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