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CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses
[UPDATED 12/09/2011] FDA Class I Recall notice updated.
[UPDATED 11/18/2011] CooperVision announced an expansion of its worldwide recall of the Avaira brand product line of contact lenses because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue. Customers can go to www.coopervision.com/international-recall to check the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled.
AUDIENCE: Eye Care, Consumers
ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
BACKGROUND: Used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single-use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
On August 19, 2011, the firm sent a recall notification letter to the US and Canadian distributors and health care practitioners. These lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.
RECOMMENDATION: Consumers should return their lenses to their eye care practitioner if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/14/2011 - Recall Notice - FDA]