Visionsense, Ltd.August 4, 2022

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

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Record Details

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.

Company: Visionsense, Ltd.
Inspection Date: August 4, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Catherine J. Laufmann (Consumer Safety Officer)

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ID · ea8fd7c7-5ff6-4a90-83b7-f46038be7118