FDA Struggles To Contain IOL Competitive Claims, Issues Pharmacia Warning
This article was originally published in The Gray Sheet
Executive Summary
Pharmacia is the third intraocular lens company in the last three years to be cited by FDA for improper marketing claims related to posterior capsule opacification (PCO).
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Ciba “square-round-edge” IOL
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)...
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