BACKGROUND

 

In 2005, the FDA received complaints from patients who were very dissatisfied with their Quality of Life (QOL) after LASIK surgery.  The agency convened a Postmarket Issue (PMI) Action Team to systematically assess the available data and provide recommendations on whether further action by FDA is needed, after noting the following:

 

·         The severity and frequency of the symptoms described by these patients were different from the results in clinical studies reviewed by the FDA.

·         Several years have passed since the FDA’s approvals, so the data from widespread distribution of the devices could be different from those supporting the approval decisions.

·         The reported problems were not among the data that FDA received in manufacturers’ annual reports about the devices.

·         The reported problems were not among the general feedback that FDA has been receiving from the healthcare community.

 

 

PMI ACTION TEAM’S ACTIVITIES

 

The primary task before the PMI Team was to compare the scientific evidence upon which the FDA based its approval decisions (premarket data) against the data that have surfaced since the approvals (postmarket data.). Quality of Life (QOL) data from all of the Premarket Approval (PMA) applications for approved LASIK devices were evaluated by the team. Additionally, the Team looked at the literature articles about “patient satisfaction” and “quality of life” associated with LASIK, and voluntary and mandatory adverse event reports sent to the FDA.

 

The Team noted that overall QOL information in the medical literature did not suggest significant problems with LASIK surgery. The data showed that the vast majority of patients were satisfied with their outcomes; however, a small percentage of patients were dissatisfied.  The Team also noted that QOL issues related to LASIK had not been evaluated consistently, and there were few reports of well-designed studies of QOL post-LASIK.  Therefore, valid statistical comparison to QOL parameters assessed in pre-market data was not possible.

 

At the conclusion, the Post-LASIK QOL PMI Action Team recommended that the FDA consider a large, national, prospective study to accurately quantify the small proportion of dissatisfied LASIK patients and evaluate the reasons for their dissatisfaction.