CooperVision, FDA Steps Up Public Warning About Recalled Contact Lenses
Nearly two months after problems were first announced, contact lens giant CooperVision Inc. and federal health regulators have amped up public warnings about more than half a million recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.
The federal Food and Drug Administration on Friday posted a Class I recall warning about CooperVision’s Avaira Toric contact lenses, which were first recalled Aug. 19 because of unidentified and unintended residue left behind during manufacturing.
Class I recalls are the most serious kind of recall and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
Despite the FDA issuing a Class I recall, CooperVision merely states “hazy vision and discomfort” result from wearing the lenses. Yet the FDA, after claims of torn corneas, advises “should immediately remove their existing lenses, discontinue all lens wear, and return them to their eye care practitioner or point of purchase.”
There is a clear disconnect between CooperVision who has kept the recall largely under wraps. CooperVision customers who read the company’s recall page should take the recall notice seriously. Return the lenses and visit your eye care practitioner.
Below is an image of the label on the recalled lenses:
- No comments Posted in: Medical Device News (FDA), Medical Device Recall Tags: 6-Pack Carton, Avaira, Avaira Toric contact lenses, Avaira Toric recall, Blister Label, contact lens recall, contacts, Cooper Vision, CooperVision Inc., CooperVision Inc. recall, Costco, Fairport, FDA, Lens Crafters, Recall, Toric, Wal-Mart
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