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Medical Devices / Regulatory Affairs

FDA Expert Panel Seeks Solutions for Peroxide Contact Lens Risks

March 29, 2017

Peroxide-based contact lens product labels need clearer warnings and instructions for use to prevent adverse events, according to an FDA advisory panel.

The Ophthalmic Medical Devices Panel of the FDA’s Medical Devices Advisory Committee and Risk Communications Advisory committee met in Gaithersburg, Md., to discuss risks associated with peroxide-based contact lens products. According to the panelists, there are many more adverse events — such as burning or irritation — caused by misusing hydrogen peroxide solution than are being reported to the FDA.

Panelists said warning labels and instructions for use should be simpler and more consistent. Most panelists also agreed that the hydrogen peroxide warning statement should be more prominent on the box and label and should include a red label warning sign.

Most panelists said the case and bottle should be redesigned to be functionally dependent to reduce human error. Currently, one can be used without the other.

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