Torn Corneas, Vision Problems Follow ‘stealth recall’ of Contact Lenses
MSNBC is reporting amid growing reports of eye problems ranging from blurry vision to torn corneas, federal health officials are threatening to issue a public warning about recalled contact lenses manufactured by CooperVision Inc. and sold widely at stores such as Costco, Wal-Mart and LensCrafters.
The Fairport, N.Y., firm has yet to heed a request from the federal Food and Drug Administration to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August because of unidentified “residue.”
“Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses,” FDA spokeswoman Morgan Liscinsky said in an e-mail.
Medical device recalls are voluntary but the FDA can impose a range of severe penalties if a company does not comply with the agency in recalling a product. This includes a maximum of $15,000 per violation of the FD&C Act, with a cap of $1,000,000 per proceeding. CooperVision will likely face penalties in the coming weeks because of the way it handled this recall. Medical device companies (distributors, initial distributors/importers, manufacturers) should consult legal counsel when notified of a product recall. The need to timely manage a recall and possibly file a Medical Device Report (MDR) all require smooth and prompt navigation of the Food Drug and Cosmetics Act and related regulations (21 CFRs).
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