Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

RT-5100 Refractor Recalled by Nidek Inc. Due to The lens bonding was incomplete on the refractor.

Date: June 14, 2018
Company: Nidek Inc.
Status: Terminated
Source: FDA (Device)

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, a component of the Epic-5100 System.

Quantity: 85 instruments

Why Was This Recalled?

The lens bonding was incomplete on the refractor.

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)Not affected

About Nidek Inc.

Nidek Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report