LASIK Panel Reaches Consensus On Labeling Changes
This article was originally published in The Gray Sheet
Executive Summary
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
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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.
Regulatory News In Brief
Grassley probes Medtronic consultant: Sen. Chuck Grassley, R-Iowa, is gathering information about a former Walter Reed Army Medical Center surgeon accused of falsifying data and forging signatures for a study of Army soldiers treated with Medtronic's Infuse bone graft for lower leg injuries sustained in Iraq. Timothy Kuklo, an associate professor of orthopedic and neurological surgery at Washington University School of Medicine in St. Louis, currently on leave, is a paid consultant to Medtronic. Grassley sent letters May 15 and May 18 to Medtronic, Walter Reed, Washington University and The Journal of Bone and Joint Surgery - which published Kuklo's study last year but later retracted it - seeking details on Kuklo's financial ties. Grassley also questioned why Kuklo was not included in Medtronic's list of physician consulting agreements related to Infuse, which the senator requested last October
Regulatory News In Brief
Grassley probes Medtronic consultant: Sen. Chuck Grassley, R-Iowa, is gathering information about a former Walter Reed Army Medical Center surgeon accused of falsifying data and forging signatures for a study of Army soldiers treated with Medtronic's Infuse bone graft for lower leg injuries sustained in Iraq. Timothy Kuklo, an associate professor of orthopedic and neurological surgery at Washington University School of Medicine in St. Louis, currently on leave, is a paid consultant to Medtronic. Grassley sent letters May 15 and May 18 to Medtronic, Walter Reed, Washington University and The Journal of Bone and Joint Surgery - which published Kuklo's study last year but later retracted it - seeking details on Kuklo's financial ties. Grassley also questioned why Kuklo was not included in Medtronic's list of physician consulting agreements related to Infuse, which the senator requested last October