Ora System 2000 Intraopertive Wavefront Aberrometer

Recall Summary The Ora System 2000 Intraooperative Wavefront Aberrometer, a device used during eye surgery to measure optical irregularities, is being recalled across Canada due to a software issue that could cause inaccurate measurements. This device is used by eye care professionals in surgical settings, not by consumers directly. The recall affects all units of this medical device that were distributed in Canada.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-08-14

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4a48bc6f-1b15-457e-bdb2-001b0b4ff677