Devices

Device Recall Epic 5100) Refractor and RT 3100 Refractor

Model / Serial
serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
Manufacturer
Nidek Inc
1 Event
- Recall of Device Recall Epic 5100) Refractor and RT 3100 Refractor

Manufacturer

Nidek Inc

Manufacturer Address
Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
Manufacturer Parent Company (2017)
Nidek Co. Ltd.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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