Recall Z-0655-2019— Nidek Inc.
Class III · Terminated
Class III FDA medical device recall by Nidek Inc., initiated 2018-06-14, terminated 2020-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: RT-5100 Refractor, a component of the Epic-5100 System.. Reason: The lens bonding was incomplete on the refractor..
- Recalling firm
- Nidek Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-06-14
- Terminated
- 2020-06-03
- Firm location
- Fremont, CA, United States
Product description
RT-5100 Refractor, a component of the Epic-5100 System.
Reason for recall
The lens bonding was incomplete on the refractor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.