CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses
AUDIENCE: Eye Care, Consumer
ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira (enfilcon A) Sphere Soft Contact Lens. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
BACKGROUND: Used for the correction of myopia or hyperopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
On November 19, 2011, the firm sent a recall notification letter to the US distributors and health care practitioners. These lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011.
RECOMMENDATION: Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice. Avaira Sphere contact lens wearers should check CooperVision’s recall web site www.coopervision.com/international-recall to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Alternatively, consumers can contact CooperVision’s toll-free consumer hotline at 1-855-526-6737 (M-F, 9:00 am – 5:00 pm EST). If you discover your lenses are among the recalled lots, return them to the point of purchase or to your eye care practitioner.
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
[12/07/2011 - Recall Notice - FDA]
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