483
LENSAR, Inc.LENSAR, Inc. – FDA 483, Sep 21, 2022
Record Details
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.
View Company Profile
ID · 929bf968-304c-4cbe-8930-73f63a82afc6
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.