Nidek recalls specific ARK-1s models due to possible dioptric value differences between subjective and objective measurement modes. Affected units may have inaccurate eye measurements.
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Nidek is recalling certain AUTO REF/KERATOMETER ARK-1s models because they might show different dioptric values in subjective versus objective measurement modes. This could lead to inaccurate eye measurements during vision testing.
The device may produce inconsistent results between its subjective (patient-reported) and objective (machine-measured) eye tests. This difference could cause inaccurate refractive error measurements, potentially affecting treatment decisions.
Ophthalmologists and eye care professionals who use the ARK-1s for eye measurements are likely affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your device has the model number ARK-1s and one of the listed serial numbers (e.g., 620337, 620340, etc.). The recall covers specific units sold with these serial numbers.
Look for the serial number on your device to see if it matches the list of affected numbers provided in the recall.
The recall is due to a possible difference in dioptric values between the subjective and objective measurement modes on these devices, which could lead to inaccurate eye measurements.
No, the recall does not require stopping use. The device can still be used but users should verify measurements with a different method if accuracy is critical.
Check your device's serial number against the list provided in the recall. If affected, contact Nidek for further instructions.
We’ve drafted a message you can send Nidek to request your refund or repair — edit it as you like.
Subject: Recall Z-1348-2018 — Nidek Nidek Hello, I own a Nidek that is covered by recall Z-1348-2018 from Nidek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
