Medical device recalls

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

Recall date
June 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0655-2019
FDA classification
Class III
Brand / firm
Nidek Inc.
Sold / distributed
Distribution was made to FL.

Why it was recalled

The lens bonding was incomplete on the refractor.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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