Z-0108-2019 Class II Terminated
FDA device recall Z-0108-2019 was initiated by Carl Zeiss Meditec AG on June 25, 2018 and is designated Class II. 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 … The recall status is terminated (terminated January 15, 2021). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- June 25, 2018
- Termination Date
- January 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
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.
Distribution Pattern
US: CA (Mountain View and San Jose) A single system. No distributed OUS.
Code Information
Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080