Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Check against the official notice below — it lists the full affected range.
Carl Zeiss Meditec AG recalled one IOLMaster 700 optical coherence tomography (OCT) device, serial number 1185393, due to a calibration error that occurred during manufacturing. The incorrect calibration setting causes the device to produce inaccurate two-dimensional images of eye structures in both the front and back portions of the eye. The affected device was distributed to a location in California (either Mountain View or San Jose) and was not distributed outside the United States.
The recall notice does not specify what consumers or healthcare providers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US: CA (Mountain View and San Jose) A single system. No distributed OUS. Quantity: 1 Lot/code info: Model: 700 Catalog Number: 000000-1932-169 Serial Number: 1185393 UDI: 04049471092080
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.