Ophthalmic Devices Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA downclassification of ocular prosthetic (artificial eye) lubricating solution from Class III to Class II is supported in a unanimous (9-0) vote at a Jan. 14 meeting in Rockville, Maryland. The panel recommended that manufacturers follow May 1, 1997 "Premarket Notification 510(k) Guidance for Contact Lens Products" as a special control. The panel also reviewed implantable and exterior eyelid weights for gravity-assisted treatment of lagophthalmos resulting from temporary or permanent facial paralysis - specifically of the orbicularis oculi muscle. The panel voted 9-0 to classify the previously unclassified implantable eyelid weights as Class II, with design controls and labeling as special controls; and the panel voted 7-2 to reclassify exterior eyelid weights from Class I to Class II exempt, with labeling as special controls
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