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-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
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Nidek Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 18, 2019 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.