Device 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.
Z-2477-2015
Product summary
- Firm
- Nidek Inc
- Event
- Event 71691
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3836
- Official record key
device-enforcement:Z-2477-2015
Official wording
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.
Code information: 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 pattern: Nationwide Distribution.
Derived failure modes
-
Device software or design
Software bug