Ciba “square-round-edge” IOL
This article was originally published in The Gray Sheet
Executive Summary
Ciba is building inventory for a planned late-2002 U.S. launch of its CV232 square-round-edge intraocular (IOL) lens following supplemental PMA approval, announced May 31. The design combines a square posterior edge, to facilitate 360-degree capsular contact, and a rounded anterior edge, to reduce glare. While Ciba believes the square posterior edge "may improve postoperative results," FDA has not approved a specific claim related to this potential advantage, and has issued warning letters to IOL manufactures claiming a square edge reduces posterior capsule opacification (1"The Gray Sheet" Oct. 8, 2001, p. 10)...