Eyecee One Preloaded
Brand(s)
Last updated
Summary
Product
Eyecee One Preloaded
Issue
Medical devices - Performance issue
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
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