Recall Z-2477-2015— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2015-06-15, terminated 2016-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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 for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.. Reason: 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..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-15
- Terminated
- 2016-04-25
- Firm location
- Fremont, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.