Reported Oct 24, 2018 · Terminated

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

Carl Zeiss Meditec AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carl Zeiss Meditec AG · Carl-Zeiss-Promenade 10 · Jena, N/A · N/A

Is this the product you have?

    • Carl Zeiss Meditec AG
    • Goeschwitzer Strasse 51-52 07745 Jena
    • Germany
    • IOLMaster 700
    • REF 1932-169 SN 1185393 2017-09-01
Lot codes and dates
  • Model700
  • Catalog Number000000-1932-169
  • Serial Number1185393
  • UDI04049471092080
Amount recalled
1

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 15, 2021 · Data as of Sep 19, 4:15 PM UTC

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