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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74595

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 01, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nidek Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2587-2016
Recall number
Z-2587-2016
Initiated
July 01, 2016
Classification
Class II
Status
Terminated
Recalling firm
Nidek Inc
Quantity
17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

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