Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 2, 2014
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.
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Nidek Inc recalled RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured… - a moderate-severity action.
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured… was recalled by Nidek Inc in July 2, 2014. Reason: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient inj…. Check the official notice for the remedy. Verify recall #Z-1853-2014 with the FDA Devices before acting.
The recall
Nidek Inc issued this moderate-severity FDA Devices recall-Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient inj….
- Moderate
- severity level
- Class II
- classification
- July 2, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1853-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1853-2014) was formally reported on July 2, 2014, with the manufacturer initiating the action on June 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Nidek Inc is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as ~4,285 units RT-5100; 167 units of RT-3100.
The documented reason for this recall is: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. Distribution data in the federal record shows the product reached: US distribution only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
~4,285 units RT-5100; 167 units of RT-3100
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1853-2014 |
| Date reported | July 2, 2014 |
| Date initiated | June 9, 2014 |
| Recalling firm | Nidek Inc |
| Firm location | Fremont, CA |
| Affected scope | ~4,285 units RT-5100; 167 units of RT-3100 |
| Distribution | US distribution only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1853-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nidek Inc. Units affected: ~4,285 units RT-5100; 167 units of RT-3100.
Why was this product recalled? ▼
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1853-2014.
Where was the recalled product distributed? ▼
Distribution: US distribution only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1853-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 2, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.