Reported Apr 18, 2018 · Terminated
AUTO REF/KERATOMETER ARK-1s
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc. · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- AUTO REF/KERATOMETER ARK-1s
- Lot codes and dates
64 of 64 codes
Model No. ARK-1sSerial No. 620337620340620341620343620345620349620350620355620356620359620363620370620371620374620376620377620380620381620384620387620389620391620394620398620400620403620404620407620410620412620415620417620418620420620422620425620427620429620433620435620437620440620444620445620447620450620452620454620455620459620462620464620466620469620471620474620477620478620480
- Amount recalled
- 63 untis
Where it was sold
Why it was recalled
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
This product could cause temporary or reversible health problems — stop using it.
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