Z-1348-2018Class II

AUTO REF/KERATOMETER ARK-1s

Name: Z-1348-2018 AUTO REF/KERATOMETER ARK-1s
Creator: Nidek Inc.
Published: 2017-12-20
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2017-12-20 / Terminated / root cause: manufacturing process

FDA source

Nidek Inc. began a recall of AUTO REF/KERATOMETER ARK-1s on 2017-12-20. FDA classified it as Class II and gives the reason as "There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1348-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-04-10
Terminated: 2019-03-18
Recalling firm: Nidek Incorporated
Product: AUTO REF/KERATOMETER ARK-1s
Product code: HKO Refractometer, Ophthalmic
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Customers were notified via letter on about 12/20/2017. The letter instructed consignees that a representative from Marco Ophthalmic, Inc. will make arrangements for the affected unit to be picked up and replaced with an ARK-S unit that meets factory specifications.
Quantity in commerce: 63 untis
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1348-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1348-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code HKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)