Z-2477-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- June 15, 2015
- Termination Date
- April 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3836
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.
Distribution Pattern
Nationwide Distribution.
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.