FDA Issues Second Contact Lens Recall
By Cole Petrochko, Associate Staff Writer, MedPage Today
Published: December 08, 2011
WASHINGTON — The FDA has issued a class I recall — the agency's most serious — for a second brand of CooperVision's AVAIRA Aquaform contact lenses that may cause serious eye injury.
The AVAIRA Aquaform Sphere Soft Contact Lenses may have unintended silicone oil residue on the lens, which may cause symptoms that range from hazy/blurry vision, to discomfort, to eye injuries that require medical treatment, an FDA statement said.
The lenses are indicated to correct myopia or hyperopia in aphakic and nonaphakic patients with nondiseased eyes. The lenses may be worn by people with astigmatism of 2.00 diopters or less that does not interfere with visual acuity, the statement said.
The company issued a recall notice to distributors and healthcare professionals on Nov. 19, 2011.
CooperVision's AVAIRA Tonic Soft Contact Lenses faced a similar class I recall in October due to the presence of silicone residue.
The company has set up a website for patients to check their lens package lot number to see if their contacts have been recalled.
Patients should cease use of the affected lenses and contact a healthcare professional immediately, the FDA said in the statement.
Class I recalls are reserved for products with a reasonable risk of causing serious adverse events or death with use.
Class Action Lawyer Network attorneys accepting clients for Avaira Class I recall with complications. If you have been injured by Avaira Coopervision Contact lenses call now.
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