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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