Z-2477-2015Class II

OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02...

Name: Z-2477-2015 OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02...
Creator: Nidek Inc
Published: 2015-06-15
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2015-06-15 / Terminated / root cause: software

FDA source

Nidek Inc began a recall of 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... on 2015-06-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2477-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Posted: 2015-08-27
Terminated: 2016-04-25
Recalling firm: Nidek Incorporated
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.
Product code: HKO Refractometer, Ophthalmic
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 3836
Distribution: Nationwide Distribution.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2477-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2477-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27

Product code HKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)