Z-0108-2019Class II

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

Name: Z-0108-2019 Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393...
Creator: Carl Zeiss Meditec AG
Published: 2018-06-25
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2018-06-25 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Meditec AG began a recall of Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01 on 2018-06-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0108-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-25
Posted: 2018-10-15
Terminated: 2021-01-15
Recalling firm: Carl Zeiss Meditec Inc
Product: Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Product code: HJO Biomicroscope, Slit-Lamp, Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 08/06/2018 the firm sent a Field Safety Corrective Action letter to customers via FedEx Priority Overnight service informing them that based on routine post market surveillance activities, we have information that this specific IOLMaster 700 device is incorrectly calibrated. The calibration value for axial length measurement was not entered correctly in the device settings during the manufacturing process. The transmission discrepancy leads to an error during the axial length measurement of approx. 0.25mm. A deviation in the axial length of this magnitude results in an error of Single unit. approx. 0.8 Diopter with regard to the intraocular lens. This in turn results in a refractive error of about 0.5 Diopter. The local firm's service organization will remove this device from the field. The device manufacturer will recalibrate the device to ensure it meets specifications. Hazard involved: The likelihood of a faulty entered calibration value for axial length measurement in the production process of IOLMaster 700 is considered rare. The probability of injury, i.e. reduced visual acuity due to the implantation of a wrong IOL power, is very likely for the affected device, because the axial length of the eye cannot be measured correctly. The device failure may only be recognized through post-surgical examination. Affected product: Quantity: 1 Product Name: IOLMaster 700 Product Number: 000000-1932-169 Device Serial Number: 1185393 Manufacturing Date: 2017-09-18 Actions to be taken: 1. Discontinue use of the ZEISS IOLMaster 700 device (Serial Number 1185393). Physicians are asked to review refractive results during usage of this device and to inform the firm about any hyperopic refractive surprises noticed. Any measurement and calculation data from this device should not be taken into consideration for further treatments. 2. Complete and return the attached Medical Device Recall Return Response Form to [email protected] no later than Jun
Quantity in commerce: 1
Distribution: US: CA (Mountain View and San Jose) A single system. No distributed OUS.
Product codes and lots: Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-15

Product code HJO

K170171Class IIIOLMaster 700Carl Zeiss Meditec, AG / cleared 2017-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)