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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81000

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

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Event summary

Timeline bucket
June 25, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carl Zeiss Meditec AG

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

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

Z-0108-2019
Recall number
Z-0108-2019
Initiated
June 25, 2018
Classification
Class II
Status
Terminated
Recalling firm
Carl Zeiss Meditec AG
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

Code information

Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080

Distribution pattern

US: CA (Mountain View and San Jose) A single system. No distributed OUS.