FDA recall Z-0655-2019
Nidek Inc. · Class III · device
Product
RT-5100 Refractor, a component of the Epic-5100 System.
Reason for recall
The lens bonding was incomplete on the refractor.
Distribution
Distribution was made to FL.
Key facts
- Status
- Terminated
- Initiation date
- 2018-06-14
- Report date
- 2018-12-26
- Termination date
- 2020-06-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Fremont, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2019