Devices

Summary of Panel VisAbility System Discussion

Members of the FDA Ophthalmic Devices Panel voted 11/9 to recommend against approval of the Refocus Group’s VisAbility Micro Insert System with a proposed indication for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between 45 and 60 years old with specified manifest spherical equivalents. A summary of the panel discussion says members voted 1-13-2 that there is no reasonable assurance that the system is safe for use in patients who meet the criteria specified in the proposed indication, 3-13-0 that the system is effective, and 1-15-0 that the benefits of the system outweigh the risks.

Panel members said the safety issues are concerning from the perspective of an elective procedure for someone who has healthy eyes and is looking for alternatives to contacts or glasses for presbyopia. They expressed concern not knowing long-term issues and the potential impact on any future procedures that patients may have to undergo, the summary says.

Panelists expressed several concerns about the design of the clinical trial submitted to support the application and concerns about the quality of the patient-reported outcomes instrument and its results.

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