Recall Z-1348-2018— Nidek Inc.
Class II · Terminated
Class II FDA medical device recall by Nidek Inc., initiated 2017-12-20, terminated 2019-03-18. FDA's recall record names no specific 510(k) clearance for this event. Product: AUTO REF/KERATOMETER ARK-1s. Reason: There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s..
- Recalling firm
- Nidek Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-20
- Terminated
- 2019-03-18
- Firm location
- Fremont, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.