Nidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction
Nidek Inc is recalling RT-5100 and RT-3100 refractors because the Near Point Chart Arm may lower spontaneously, posing a risk of slight injury to the patient's face or nose.
What this means for you
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 2,703 units of the RT-5100 (Epic 5100) and RT-3100 refractors. These instruments are used to position lenses and prisms in front of a subject's eye to determine refractive error and binocular functions. The recall involves 128 RT-3100 units and 2,565 RT-5100 units distributed nationwide in the United States.
The recall is due to a reoccurrence of an issue where the Near Point Chart Arm lowers spontaneously. This malfunction creates a potential for slight injury to the face or nose of the patient. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and consumers should identify affected units by checking the serial numbers against the attached distribution list. The source text does not specify a corrective action or contact information for the recalling firm.
The recalled product
- Product
- 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
- Affected units
- 2,703
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 (1)
- serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
Distribution
Distributed nationwide across the United States.
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