# FDA 483 - LENSAR, Inc. - September 21, 2022

Source: https://www.globalkeysolutions.net/records/483/lensar-inc/929bf968-304c-4cbe-8930-73f63a82afc6

> FDA 483 for LENSAR, Inc. on September 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LENSAR, Inc.
- Inspection Date: 2022-09-21
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of LENSAR, Inc. in Orlando, FL, a manufacturer of medical devices, identified one observation. The firm failed to submit a required Radiation Safety Product Report for its LENSAR ALLY™ Adaptive Cataract Treatment System before distributing the product into interstate commerce. This indicates a moderate administrative non-compliance related to product reporting requirements for laser systems.

## Related Officers

- [Natasha R. Johnson](https://www.globalkeysolutions.net/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.globalkeysolutions.net/companies/lensar-inc/768e79dd-d0c9-4b28-8219-e188878bb08b

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6