FDA Device recall Z-2587-2016

OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier

• FDA Device
• Class II
• terminated
• Published 2016-08-24

On 2016-08-24 the FDA classified a Class II recall of OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier by Nidek, citing nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

Read the official FDA Device notice

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.

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2587-2016%22

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