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Nidek Inc. recalls RT-5100 Refractor, a component of the Epic-5100 System.
Recalled December 26, 2018 · FDA recall Z-0655-2019 · Nidek
Hazard
The lens bonding was incomplete on the refractor. · FDA Class III
Units
85 instruments
Sold at
Distribution was made to FL.
Description
The lens bonding was incomplete on the refractor.
Product
RT-5100 Refractor, a component of the Epic-5100 System.
Manufacturer(s)
Nidek Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →