Carl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings
Carl Zeiss Meditec AG is recalling one IOLMaster 700 system because a manufacturing error caused incorrect calibration, leading to inaccurate eye images.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that produces incorrect diagnostic images, which poses a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Carl Zeiss Meditec AG is recalling one IOLMaster 700 optical coherence tomography (OCT) system. The recall was initiated because a calibration setting was incorrectly entered during the manufacturing process.
This error caused the device to obtain incorrect two-dimensional images of the ocular structures in the anterior and posterior segments of the eye. The affected unit is identified by Reference 1932-169 and Serial Number 1185393.
The single system was distributed to facilities in Mountain View and San Jose, California. No other units were distributed outside the United States. Users of the affected device should contact the manufacturer for further instructions.
The recalled product
- Product
- Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
- Manufacturer
- Carl Zeiss Meditec AG
- Affected units
- 1
Distribution
Distributed in 1 state:
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