San Jose-Based Invisalign Maker Gets FDA Warning
SAN JOSE (AP) — The Food and Drug Administration has issued a warning to a San Jose-based company that makes a popular teeth straightener about its failure to report information about patient side effects.
Align Technology, which makes the Invisalign system, disclosed this week that it received a Nov. 18 warning letter from the FDA.
The letter accused the company of failing to comply with federal requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.
Align Technology CEO Thomas Prescott said that the side effects have only affected a small percentage of its 1.3 million patients. The company also said it had replied to the FDA to resolve the matter.
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