FDA 483 - MicroVision, Inc. - October 03, 2019

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.