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Medical Device Recall and Crisis Response

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There have been countless recalls of faulty drugs and medical devices in the pharmaceutical and device industry. Some have been the result of malicious actions by external parties, while others can be attributed to production faults or other random incidents. No matter what the cause, the manufacturer is always placed directly in the spotlight and how they respond can have lasting effects on their reputation.

The most recent to capture the media’s attention – as they inevitably always do – is a voluntary recall of around 600,000 contact lenses made by New York-based CooperVision, Inc. Federal health officials claim that an “undefined residue” on the lenses has caused a range of eye problems, from blurred vision to painful corneal tears.

CooperVision has come under heavy criticism for their slow response to the recall. This delay has resulted in threats by the FDA to issue a public health warning and sweeping negative media coverage for CooperVision. As a voluntary recall, the Food and Drug Administration, which regulates contact lenses as a class III medical device, has only limited authority to force CooperVision into action, with much of the onus for notification and action placed on the individual retailers.

While reports note that the company is stepping up its response and communication to patients, with the company issuing a fresh press release on 10.12.11, concerned consumers may still be in the dark. The Avaira® Toric brand in question is still being actively promoted on the corporate website and while there is a button for those “Looking for information about Avaira® Toric” it is not abundantly clear that this is an issue and feels almost promotional [Note: the button was subsequently updated to include the word “Recall”].

CooperVision was slow to update the social media space, the new go-to for real-time consumer updates, with CooperVision’s corporate Facebook page posting information on the recall only after their second press release, while Twitter was afire with media reports on the incident.

This recall may impact only a portion of the CooperVision’s bottom line, however for less diversified organizations, the impact could have been far greater.  Consumers react quickly to threats to the health and wellbeing of them and their families. In the crowded pharmacy and medical device marketplace, consumers will not blink twice (pardon the pun) at switching brand and going to a competitor if they feel their health is at risk. Coupled with aggressive legal forces, constantly looking for the next class-action suit, along with twitchy regulators, inaction on the face of a crisis could quickly bring down a company.

CooperVision, like countless others before them, have been placed, by no fault of their own, in the spotlight. This incident once again underlines the fact that preparing for, and proactively addressing a crisis is of paramount importance in maintaining trust and mitigating brand damage.


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