fbpx

FDA Threatens Public Warning After Stealth Recall of Contacts

Media outlets reported that federal health officials are threatening to issue a public warning concerning recalled contact lenses manufactured by CooperVision Inc. and distributed to stores such as CostCo, Wal-Mart and Lenscrafters because of the company’s refusal to broaden their notification of problems with the lenses.

The firm has refused to comply with the request of the US Food and Drug Administration that they broaden the notification of problems concerning lots of their Avaira Toric contact lenses, which were recalled in August due to an unidentifiable “residue”, but improperly publicized.

FDA spokeswoman Morgan Liscinsky said, “Absent prompt and adequate communication with CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses.”

CooperVision Inc. officials initiated a voluntary recall on what they referred to as “a limited number of lots”, amounting to roughly 10 percent of the Avaira Toric contact lenses sold or issued as samples over the previous year. The company claimed the recall was due to receiving a “small number of unexpected wearer reports of hazy vision and discomfort.” Many US consumers were notified on the recall date or shortly thereafter however, the FDA claims that the recall notifications issued overseas were more widespread. The FDA is asking that the company widen their notification in the US, but the FDA does not have the authority to demand this action.

Liscinsky said, “We are requesting that the firm issue a broader statement to ensure that users are aware of the recall.”

CooperVision officials replied to the FDA in a statement, saying the firm “has fully cooperated with the FDA and continues to closely monitor the situation and seek advice from FDA during this process.”

As a Renton personal injury lawyer, I’ve witnessed similar recalls in the past and understand the impact they can have on people’s lives. If you have been injured by a defective product, speak with a personal injury lawyer in your city about your legal options.