FDA-Device2018-12-26Class III
RT-5100 Refractor, a component of the Epic-5100 System.
Nidek Inc.
Hazard
The lens bonding was incomplete on the refractor.
Sold states
Distribution was made to FL.
Affected count
85 instruments
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
RT-5100 Refractor, a component of the Epic-5100 System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2019Don't want to check this manually?
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