CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Optical Biometer Al-Scan recalled by Nidek

Nidek is recalling Optical Biometer Al-Scan, distributed nationwide in the US. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOPTICAL 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.

Quantity recalled17

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2587-2016
FDA event ID: 74595
Recalling firm: Nidek, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 1 Jul 2016
FDA classified: 17 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Contact Lenses & Eye Devices

Timeline

1 Jul 2016	Recall initiated by company
17 Aug 2016	Classified by FDA	+47 days
24 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.

Nationwide Arizona Delaware Georgia Maine Missouri New Mexico New York Pennsylvania Tennessee Virginia

Questions about this recall

Is Optical Biometer Al-Scan recalled?

Yes. Nidek recalled Optical Biometer Al-Scan on 1 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2587-2016.

Why was it recalled?

Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

Which lots are affected?

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.

Where was it sold?

US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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