Draft FDA Guidance Aims To Ensure Patients Understand LASIK Risks
The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications.
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Patient labeling for LASIK laser vision correction systems should be modified to include graphics of what potential visual side effects like halos and starbursts could look like, according to FDA's Ophthalmic Devices Panel
Indiana Republican Congresswoman Jackie Walorski, who died in a car crash Wednesday, was a strong proponent of device industry priorities such as device tax repeal and Medicare coverage for innovative technologies.