CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic recalled
Nidek is recalling OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic, distributed nationwide in the US. The recall was initiated on 15 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2477-2015
- FDA event ID
- 71691
- Recalling firm
- Nidek, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2015
- FDA classified
- 27 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Jun 2015 | Recall initiated by company | |
| 27 Aug 2015 | Classified by FDA | +73 days |
| 2 Sep 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic recalled?
Yes. Nidek recalled OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic on 15 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2477-2015.
Why was it recalled?
Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
Which lots are affected?
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.
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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