Complaints about Lasik eye surgery using lasers made by companies including Alcon and Advanced Medical Optics will be investigated as part of a wider study on how having the procedure affects patients' quality of life.
As reported in Optician, (News, March 28), the US Food and Drug Administration (FDA) announced the inquiry following a number of concerns about patient satisfaction with the procedure.
News agency Bloomberg reported last Friday that the FDA had received 140 reports of side effects with Lasik from 1998 to 2006 and that the study is scheduled to start by 2009.
The regulatory body has also had representations made to it by patients who are unhappy with the outcome of their laser eye surgery and want more done to limit poor results.
At a press conference last week, David Schultz, head of the FDA's medical devices center, told reporters that identifying why complications occurred would help those considering Lasik make more educated choices.
He added: 'Clearly there is a group (of patients) that aren't satisfied and don't get the results that they expect. Studying these patients is very high on the agency's priority list.'
In a separate development, the American Academy of Ophthalmology confirmed that its board of trustees had approved a proposal to co-fund the FDA driven study.
'No surgery is without risk, but as physicians we are dedicated to doing everything in our power to make the Lasik procedure even better for our patients,' said H Dunbar Hoskins Jr, executive vice president of the Academy, in a statement. 'Exploring how Lasik impacts quality of life may uncover opportunities for improvement that can benefit all patients.'