483
MicroVision, Inc.FDA 483 - MicroVision, Inc. - October 03, 2019
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Record Details
An FDA inspection of MicroVision, Inc. in Seabrook, NH, conducted from October 1-3, 2019, identified one significant observation. The firm failed to submit a Medical Device Report (MDR) within the required 30-day timeframe after becoming aware of an adverse event related to a Chandelier Fiber device malfunction. This indicates a serious lapse in regulatory reporting compliance.
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ID · ab764b44-d35d-41b4-94da-31fad7e9a53e