Health product recall

Eyecee One Preloaded

Brand(s)
Last updated

Summary

Product
Eyecee One Preloaded
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Eyecee One Preloaded

More than 10 numbers, contact manufacturer.

SZ-1

Eyecee One Crystal Preloaded

More than 10 numbers, contact manufacturer.

SZ-1C

Issue

Since the end of November 2022, Nidek has received reports from EU countries about elevated intraocular pressure after implantation of Eyecee One Preloaded and Eyecee One Crystal Preloaded. Concerned about the possibility of a similar trend occurring in other countries, Nidek decided to the suspension of use of these devices as a precautionary measure, until results of the investigation are available, to all countries in the world where the affected device are marketed, including Canada.

Recall start date: February 03, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Nidek Co., Ltd.

34-14 Maehama, Hiroishi-Cho, Gamagori, Aichi-Ken, Japan, 443-0038

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73125

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe