Nidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury
Nidek Inc is recalling RT-5100 and RT-3100 refractors because the near point chart arm may lower spontaneously, posing a risk of patient injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Nidek Inc is recalling approximately 4,285 units of the RT-5100 Refractor and 167 units of the RT-3100 Refractor. These instruments are manufactured by NIDEK CO., Ltd. in Aichi, Japan, and distributed in the United States by MARCO Opthalmic. The devices are used to position spherical and cylindrical lenses, prisms, and other optical devices in front of a subject's eyes to determine refractive error and binocular functions.
The recall is due to a defect where the near point chart arm of the refractors may lower spontaneously. This malfunction creates a potential for patient injury. The affected units have various serial numbers.
Consumers and healthcare providers should stop using the affected RT-5100 and RT-3100 refractors immediately. Nidek Inc is the recalling firm responsible for addressing this issue.
The recalled product
- Product
- 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…
- Manufacturer
- Nidek Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- RT-5100 and RT-3100
- various serial numbers.
Distribution
Distribution scope not specified by the agency.
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