FDA Device recall Z-1348-2018
AUTO REF/KERATOMETER ARK-1s
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of AUTO REF/KERATOMETER ARK-1s by Nidek, citing there is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nidek |
| Distribution | 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 |
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.
Identifiers
| code_info | Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 62…Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Nidek
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium e…
FDA Device · Class III · 2020-01-08 · Nidek - RT-5100 Refractor, a component of the Epic-5100 System
FDA Device · Class III · 2018-12-26 · Nidek - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek - OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
FDA Device · Class II · 2016-08-24 · Nidek
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2018%22
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