# FDA 483 - Visionsense, Ltd. - August 04, 2022

Source: https://www.keypedia.com/records/483/visionsense-ltd/ea8fd7c7-5ff6-4a90-83b7-f46038be7118

> FDA 483 for Visionsense, Ltd. on August 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Visionsense, Ltd.
- Inspection Date: 2022-08-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Visionsense, Ltd. in Petach, Tikva, Israel, identified a significant issue with service report documentation. Specifically, repair records for a Beam Combiner involved in a serious medical device report (MDR) lacked required information, including details about a new part design. This deficiency is concerning as the device malfunction led to a patient undergoing open surgery.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/visionsense-ltd/58d64ba4-c80d-4605-b06d-773f8de7c62e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd