Recall Z-2477-2015
Nidek Inc · initiated June 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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.
FDA-determined cause: Software design
Action taken
Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan. Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.
Details
- Recall number
- Z-2477-2015
- Initiated
- June 15, 2015
- Posted by FDA
- August 27, 2015
- Terminated
- April 25, 2016
- Product code
- HKO – Refractometer, Ophthalmic
- Quantity
- 3836
- Distribution
- Nationwide Distribution.
- Recalling firm
- Nidek Inc, Fremont, CA