Carl Zeiss Meditec AG: Medical Device Recall in 2018 - (Recall #: Z-0108-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 25, 2018

Date Posted: October 24, 2018

Recall Number: Z-0108-2019

Event ID: 81000

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.

Status: Terminated

Product Quantity: 1

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.

Voluntary or Mandated:

Voluntary: Firm initiated