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Risks of Lasik must be explained warns FDA

Eye health
Promotional material and advertisements for Lasik corrective surgery must inform consumers of the risks associated with the procedure US regulator, the Food and Drug Administration (FDA) has warned.

Promotional material and advertisements for Lasik corrective surgery must inform consumers of the risks associated with the procedure US regulator, the Food and Drug Administration (FDA) has warned.

In a letter to providers of the procedure the watchdog said that advertisements and price promotions did not always convey necessary warnings about side-effects and that other precautions were deceptive.

'Advertising and promotional materials for FDA-approved lasers used during Lasik procedures must be truthful, properly substantiated and not misleading,' wrote Timothy Ulatowski, head of the Office of Compliance for the FDA's Centre for Devices and Radiological health.

The letter was issued following an investigation by the FDA over patient complaints about how Lasik had induced symptoms including blurriness, double-vision and depression.

From now on if advertising is deemed to be misleading it will issue warning letters as well as possibly fines or make referrals for criminal investigation, the regulator warned.

The FDA warning comes just weeks after an undercover Which? investigation in the UK which concluded that some of the leading high street clinics were giving unsatisfactory advice about the risks associated with laser surgery and pressuring consumers into treatment options that cost hundreds of pounds more than the advertised price (News 01.04.09). More than half of the clinics visited by Which? researchers included chains such as Optical Express, Optimax and Ultralase.

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