Z-2587-2016Class II

OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a...

Name: Z-2587-2016 OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a...
Creator: Nidek Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2016-07-01 / Terminated / root cause: software

FDA source

Nidek Inc began a recall of OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit... on 2016-07-01. FDA classified it as Class II and gives the reason as "Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement". 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-2587-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-08-18
Terminated: 2016-12-22
Recalling firm: Nidek Incorporated
Product: OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
Product code: HJO Biomicroscope, Slit-Lamp, Ac-Powered
Reason for recall: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Dear Doctor/Recall letters were sent to affected customers on July 7, 2016. The letters describe the issue and provide instruction should the issue occur. The letters inform users that Nidek will reach out in the next few weeks to schedule installation of new software that will solve the problem. Questions or concerns may be directed to: Customer Service 1.800.722.0219; Monday- Friday 8 am to 5pm PST E-mail: [email protected].
Quantity in commerce: 17
Distribution: US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
Product codes and lots: OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2587-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

Product code HJO

K133132Class IIOptical Biometer Al-ScanNidek Co., Ltd. / cleared 2014-06-11

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)