Contact Lens Manufacturer Cited for MDR Violations

The FDA considers The Lifestyle GP’s daily wear contact lenses adulterated after discovering several deficiencies in the company’s medical device reporting (MDR) and quality procedures documents, according to a warning letter.

Because the firm combined the reporting obligations of its vigilance and MDR systems, it is “difficult for employees to follow and make accurate MDR determinations,” the FDA says in the letter recently posted to its website.

The firm also was cited for failing to implement corrective and preventive action procedures, not maintaining device history records and not establishing device acceptance procedures.

The FDA also found fault with the company’s definition of “May have caused or contributed to a death, serious injury, permanent impairment of body function, or serious deterioration of health…” The letter called the definition “confusing,” said it duplicates requirements, and predicted it could “result in a failure to submit a required MDR report.”

“For example, the procedure correctly lists ‘serious injury,’ but also includes ‘permanent impairment of body function’ which is also a partial component of the MDR serious injury definition,” the letter read. “Specifically, the definition of an MDR serious injury is ‘. . .an injury or-illness that: (1) is life-threatening, (2) results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.’ “

The warning letter is available at: http://www.fda.gov/foi/warning_letters/s6965c.htm.

SOURCE: FDA NEWS