CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Carl Zeiss Meditec AG, Goeschwitzer Strasse recalled

Carl Zeiss Meditec is recalling Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, distributed in California. The recall was initiated on 25 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080

Quantity recalled1

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-0108-2019
FDA event ID: 81000
Recalling firm: Carl Zeiss Meditec, Jena, N/A
Classification: Class II
Status: Terminated
Recall initiated: 25 Jun 2018
FDA classified: 15 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Jun 2018	Recall initiated by company
15 Oct 2018	Classified by FDA	+112 days
24 Oct 2018	Published in enforcement report	+9 days

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

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.

Product as listed by the FDA

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

Where it was distributed

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

California

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

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 26 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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