PLEASANTON, Calif.—While citing the “challenges” it faced with the voluntary recall of limited lots of its Avaira product family, The Cooper Companies, Inc. (NYSE:COO) reported record financial results for the fiscal fourth quarter and full year ended Oct.31, 2011.

The company’s fourth quarter revenue rose 15 percent year-over-year to $360.9 million. In the Americas, CooperVision revenues were $136.3 million for the quarter, a 10 percent increase over the prior year. The company noted that its silicone hydrogel contact lens sales rose 41 percent to $102.7 million in the quarter, while its Proclear contact lens sales were $79.5 million for the period, an increase of 9 percent over the prior year Q4.

Gross margin was 61 percent compared with 59 percent in last year's fourth quarter. The improvement was the result of increased manufacturing efficiencies and product mix, partially offset by a reserve for costs associated with the Avaira recall, the company noted. Excluding this reserve, gross margin in the fourth quarter 2011 would have been 63 percent.

The Cooper Companies’ fiscal 2011 revenue rose 15 percent to $1,330.8 million. CooperVision’s revenue $1,121.1 million, up 16 percent from fiscal 2010, and Cooper Surgical’s revenue was $209.7 million, up 12 percent from fiscal 2010.

The company also stated that the Food and Drug Administration (FDA) “has completed inspections on two of our three manufacturing facilities (Puerto Rico and N.Y.) and no observations were received (no Form 483). We expect the FDA to inspect our U.K. facilities as well, although we are not aware of the timing at this point. The FDA has also completed an inspection of our U.S. distribution center located in West Henrietta, N.Y. We received a Form 483 with five observations and subsequently, on Dec. 7, 2011, we received a Warning Letter from the FDA. The observations are related to labeling and packaging and are not product specific. We are working closely with the FDA to resolve these observations.”

Commenting on the results, Robert S. Weiss, Cooper's president and chief executive officer said, "I am pleased to report record financial results for fiscal 2011 including record revenues at both our business units. We are proud of our many accomplishments including CooperVision's global launch of Biofinity Multifocal and its launch of Biofinity Sphere into Japan. We continued to gain market share, post solid margins, and significantly strengthen our balance sheet. While we experienced challenges such as the voluntary recall of limited lots of our Avaira product family, we remain encouraged by our business trends and believe we are well positioned to deliver strong operating results in fiscal 2012."