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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68485

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

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Event summary

Timeline bucket
June 09, 2014
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

RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.

Z-1853-2014
Recall number
Z-1853-2014
Initiated
June 09, 2014
Classification
Class II
Status
Terminated
Recalling firm
Nidek Inc
Quantity
~4,285 units RT-5100; 167 units of RT-3100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

Code information

RT-5100 and RT-3100, various serial numbers.

Distribution pattern

US distribution only.