The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2477-2015·Announced 2015-09-02

Nidek OPD-Scan III Recall for Software Aberration Calculation Error

Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software calculation error without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Nidek Inc is recalling 3,836 units of the OPD-Scan III Refractive Power/Corneal Analyzer. The affected devices are distributed nationwide and include specific software versions ranging from 1.00.08 to 1.13.01. The OPD-Scan III is a diagnostic instrument indicated for mapping the refractive error distribution of the eye by measuring spherical power, cylindrical power, and cylinder axis.

The recall is due to a software bug identified in the device. The bug causes the software to show no difference between Total and Corneal high-order aberrations, while differences are present in Internal high-order aberrations. This error affects the accuracy of the diagnostic data generated by the instrument.

Healthcare providers and facilities using the OPD-Scan III should contact Nidek Inc for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use…
Manufacturer
Nidek Inc
Category
Medical Device — Ophthalmic Diagnostic Instrument
Hazard
Affected units
3,836

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Software versions: 1.00.08 1.05.07 1.10.01
  • 1.01.02 1.06.02 1.11.02
  • 1.02.01 1.07.01 1.12.03
  • 1.03.02 1.08.01 1.13.01
  • 1.04.03 1.09.01.

Distribution

Distributed nationwide across the United States.

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