DORC Lands FDA Warning Letter for Adulterated Devices

The FDA has hit the Dutch Ophthalmic Research Center’s Zuidland, Netherlands, facility with a warning letter for manufacturing adulterated devices.

A Sept. 8, 2014 to Sept. 12, 2014, inspection revealed the plant — which manufactures the Associate 6000 phaco-fragmentation systems — does not have an approved application for premarket approval for the device, nor an approved application for an investigational device exemption.

The agency also dinged the company for the phaco-fragmentation systems being misbranded. According to the letter, DORC did not inform the FDA of modifications to the device in commercial distribution.

For example, the company changed the cutting speed of the Associate 2500 Dual and Compact Systems from 100-2,500 cycles per minute to 20-6000 cycles per minute, as well as the lighting from a halogen bulb to LED.

“The device modifications require a new 510(k) since the changes could significantly affect the safety or effectiveness of the device,” the letter says.

DORC did not respond to a request for comment by press time.

Whether you need to convince the FDA to accept a predicate device in a simple 510(k) filing, make design changes or implement UDI across a family of high-risk implantable devices, there’s one thing all regulatory professionals need — the most up-to-date, latest FDA regulations available. Get out bestselling Guide to FDA Medical Device Regulations today!