FDA recall Z-1348-2018

Nidek Inc. · Class II · device

Product

AUTO REF/KERATOMETER ARK-1s

Reason for recall

There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

Distribution

Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.

Key facts

Status
Terminated
Initiation date
2017-12-20
Report date
2018-04-18
Termination date
2019-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2018