Carl Zeiss Meditec Recalls IOLMaster 700 Devices Due to Patient Data Mismatch
Carl Zeiss Meditec is recalling 613 IOLMaster 700 devices because software versions 1.90.2.09 and 1.90.8.06 may display incorrect patient information when using the modality worklist.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential patient data errors.
Plain-English summary
Carl Zeiss Meditec AG is recalling 613 IOLMaster 700 devices. The recall involves devices with software versions 1.90.2.09 or 1.90.8.06. The devices were distributed in the United States and various international locations.
The recall is due to a software defect in the modality worklist functionality. When transferring patient data, the selection of a patient in the list may not match the patient information displayed on the right side of the screen. This discrepancy could lead to the use of incorrect patient data.
Healthcare facilities and users of the IOLMaster 700 should contact Carl Zeiss Meditec for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as this is a medical device used in clinical settings.
The recalled product
- Product
- IOLMaster 700
- Manufacturer
- Carl Zeiss Meditec AG
- Affected units
- 613
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: IOLMaster 700 Catalog Number device: 000000-1932-169
Distribution
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