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FDA Says Staar Failed to Report Complaints

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From Bloomberg News

Staar Surgical Co., a Monrovia maker of implanted contact lenses, was cited by the Food and Drug Administration for failure to ensure that complaints about the devices were properly investigated. The shares fell 18%.

The company didn’t adequately investigate complaints that it received about blurred and cloudy vision linked to its products, the agency said in a letter to the company dated Dec. 22 and posted on the FDA’s website.

The violations were found during an inspection in August and September. Staar didn’t alert the agency to reports of injuries or device malfunctions that might cause injuries, the FDA said.

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The company is required to notify the agency of steps it will take to fix the violations. A company spokeswoman didn’t return a call seeking comment.

Shares of Staar fell $1.96 to $9.22 on Nasdaq.

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