Nidek RT-5100 Refractor Recall: Incomplete Lens Bonding Risk

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Recalling firmNidek Inc.47651 Westinghouse Dr · Fremont, CA 94539-7474

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Nidek is recalling RT-5100 Refractors, a component of the Epic-5100 System, because the lens bonding was incomplete. This could lead to the refractor failing during use, potentially causing damage or injury. Affected units have specific serial numbers listed in the recall.

Why it’s dangerous

The lens bonding was incomplete on the refractor, which means the lens may not stay securely attached. This could cause the refractor to malfunction or become unstable during use, potentially leading to damage or injury.

Who’s affected

Users of the Epic-5100 System who own the RT-5100 Refractor with the listed serial numbers are affected. Those who have the refractor installed in their system are most at risk.

How to tell if you have this one

Check if your RT-5100 Refractor has a serial number from the list provided in the recall: 921042 through 921103 and 150028 through 150052.

Brand
Nidek
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Identify your RT-5100 Refractor's serial number to see if it is listed in the recall.

✎ GovInfoNow

Questions people ask

What is the specific hazard with the RT-5100 Refractor?

The lens bonding was incomplete on the refractor, which could cause it to malfunction or become unstable during use.

How can I check if my RT-5100 Refractor is affected?

Check if your serial number is in the list provided: 921042 through 921103 and 150028 through 150052.

What should I do if my serial number is affected?

Contact Nidek directly to get further instructions on the remedy.

Take action

Contact Nidek

We’ve drafted a message you can send Nidek to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0655-2019 — Nidek Nidek

Hello,

I own a Nidek that is covered by recall Z-0655-2019 from Nidek.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0655-2019 (June 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0655-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Nidek Inc. recalls RT-5100 Refractor, a component of the Epic-5100 System.

Lower-risk recall