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Recall Observatory FDA recall evidence

Device product

AUTO REF/KERATOMETER ARK-1s

Z-1348-2018

December 20, 2017

Class II

Product summary

Firm
Nidek Inc.
Event
Event 79553
Status
Terminated
Classification
Class II
Quantity
63 untis
Official record key
device-enforcement:Z-1348-2018

Official wording

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

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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