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

Source: https://www.globalkeysolutions.net/records/483/microvision-inc/ab764b44-d35d-41b4-94da-31fad7e9a53e

> FDA 483 for MicroVision, Inc. on October 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MicroVision, Inc.
- Inspection Date: 2019-10-03
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Documents

- [483 - 2023-05-25](https://www.globalkeysolutions.net/records/483/microvision-inc/dc537b49-29e5-4efe-8844-230c930de6a3)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jonathan-b-lewis/dc2d7eb9-275b-44fc-960d-9cf22d54768f)
- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/microvision-inc/fa83f1bb-e0a6-4450-a001-d97e2bb18200

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7