Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RT-5100 Refractor and RT-3100 Refractor Recalled by Nidek Inc Due to Near Point Chart Arm of RT 5100 and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
Quantity: ~4,285 units RT-5100; 167 units of RT-3100
Why Was This Recalled?
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Where Was This Sold?
US distribution only.
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report