CooperVision Expands Parameters for Avaira Toric CLs

Starting this month, CooperVision Inc. is expanding its parameters for its Avaira toric contact lenses with new +0.25D to +6.00D sphere powers to correct for hyperopia. A 2011 study indicated that 15.7 percent of hyperopes were also astigmatic. These new options join the existing parameter range, including sphere powers of plano to -6.00D in 0.25 steps; -6.50D to -10.00D in 0.50 steps; cylinder powers of -0.75, -1.25, and -1.75; and axes from 10 degrees to 180 degrees in 10 degree steps. Read more.;

FDA Clears Avaira Toric

The FDA has granted a Special 510(k) clearance for CooperVision's Avaira Toric two-week silicone hydrogel contact lenses for astigmatism, according to CooperVision. CooperVision will re-launch the toric with shipments available for select distribution beginning early May 2012. Read more.

Investor Files Suit against CooperVision

"The Shareholders Foundation, Inc. announces that a current investor in shares of the Cooper Companies, Inc. (COO) filed a lawsuit in State Court against directors at Cooper Companies over alleged breaches of fiduciary duties in connection with the recall of Avaira Toric and Avaira Sphere contact lenses," according to MSNBC. "The plaintiff alleges that defendants intentionally downplayed the breadth and impact of its quality control problems. By October 11, 2011, so the lawsuit, the Food and Drug Administration would step in and issue a Class I warning and began pressuring the Cooper Companies to provide clear notice to the public of the reasons for the recall of nearly 780,000 of its Avaira Toric lenses and the seriousness of the potential injuries." Read more.

FDA Frustrated with CooperVision's Recall

"Frustrated by a brazen disregard of its request, the U.S. Food and Drug Administration (FDA) is threatening to widely publicize potential problems with recalled contact lenses made by a western New York firm and sold in stores such as Costco, Wal-Mart and Lenscrafters," reports MPOMag. "CooperVision Inc. of Fairport, N.Y., (located nine miles east of Rochester) reportedly has failed to heed a request by the FDA to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August due to unidentified “residue.” Company executives said the recall affected about 600,000 contact lenses in the United States, or 10 percent of those sold or issued domestically as samples." Read more.