Bausch + Lomb’s said it is the only FDA-approved IOL in the United States with labeling that states “No glistenings of any grade were reported for any subject at any visit in the clinical study.” Glistenings are fluid-filled microvacuoles that can form within an IOL and may impact visual function, according to the release.
“The enVista IOL is yet another example of how Bausch + Lomb is advancing eye health innovation to meet the needs of our customers and the patients they serve,” said Cal Roberts, MD, executive vice president and chief medical officer for Bausch + Lomb, in the release. “We’ve listened to our customers tell us how frustrating glistenings can be when conducting post-surgical examinations of their patients. We are proud to offer them an attractive, viable and technologically-advanced option to address this concern.”
Bausch + Lomb’s world headquarters is in Rochester, N.Y.
Related Articles on FDA Approval:
TriReme Medical Receives FDA Clearance for Expanded Sizes of Balloon Catheter
LensAR Receives FDA 510(k) Clearance for Cataract Surgery Laser System
KFx Medical Receives FDA 510(k) Clearance for Tissue Fixation Anchor
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.