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.
Devices & Diagnostics Letter