Contact Lens Recall Expanded to Up to Nearly 5 Million of CooperVision’s Avaira Sphere & Avaira Toric, Stocks Tumble
Posted By Vicki McClure Davidson on November 16, 2011
Avaira Sphere contact lens recall has expanded to 5 million
An expanded recall of Avaira Sphere and Avaira Toric lenses due to contamination from a silicone oil residue, thus increasing CooperVision Inc.’s recall to nearly 5 million, has negatively affected the company’s stocks.
Oily residue contamination… eww. Gives me the shivers.
From Fox News, Cooper Broadens Contact Lens Recall:
Cooper Cos. (COO) has broadened a contact lens recall to include some lots of its Avaira Sphere lenses and expects a roughly $9 million charge in its fiscal fourth quarter.
Cooper in August issued a recall for some lots of its Avaira Toric contact lenses after a small number of customers complained of hazy vision after wearing them. The company’s CooperVision unit said it identified a residue on a small number of the lenses, which were first introduced in April 2010.
Tuesday, the company said it was expanding its recall as certain lots of Avaira Sphere lenses failed to meet updated quality requirements due to the level of a silicone oil residue. The company said no other product line uses silicone oil in the manufacturing process other than Avaira Sphere and Avaira Toric.
From MSNBC, Nearly 5 million contact lenses in expanded Avaira recall:
Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.
CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company’s Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.
The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.
From RTT News, Cooper Expands Recall Of Avaira Lenses:
Shares of The Cooper Companies Inc. (COO: News ) slid more than 18 percent in the afternoon session Tuesday, after its contact lenses unit CooperVision expanded a recall of some of its Avaira brand lenses.
Under the expanded recall, CooperVision is now including limited lots of Avaira Sphere contact lenses, in addition to limited units of Avaira Toric lenses.
Cooper, along with the FDA, found certain lots of Avaira Sphere lenses did not meet new quality requirements linked to silicone oil residue levels, and plans to replace them with available inventory.
The company will allocate a reserve of $9 million which will cover the expanded recall and some costs related to the Avaira Toric recall. The reserve will be taken as a charge in its fiscal fourth quarter 2011 GAAP earnings.
The total cost of the Avaira recall is now expected to be about $23.2 million, including the $14.2 million taken in the fiscal third quarter.
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