The Idesign Refractive Studio

The iDESIGN Refractive Studio software has a defect that could affect its ability to function correctly. This product is being recalled across Canada. The software is used in a medical/pharmaceutical context and has been classified as a serious safety concern.

Product

The iDESIGN Refractive Studio

Reason

Software defect

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-11-26

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c44250dc-5cfe-4e58-b5e3-6bef151f24b0