The FDA has slammed Advanced Vision Science for potentially distributing intraocular lenses in the U.S. that were rejected for the Japanese market.
The Goleta, Calif.-based company sold its PMA to Bausch & Lomb in March 2009, according to the April 6 warning letter posted online Tuesday. It also licensed the development, manufacturing and marketing for all regions except Japan.
While the company claimed it was only distributing its lenses in Japan, the letter says there is evidence that AVS has distributed certain IOLs in the U.S. since 2008 and 2012. “That is, lenses for the Japanese market that may be refused based on acceptance criteria are returned to Advanced Vision Science (AVS) and donated/distributed into intrastate commerce for further distribution.”
The FDA points out that after selling the PMA in 2009, AVS lacked an approved PMA to market the devices in the U.S., making them adulterated.
AVS did not maintain procedures on its own acceptance criteria, such as tooling marks, or on the acceptance criteria at its customers, according to the letter. After the July 27, 2015, to Aug. 3, 2015, inspection, it told the FDA it had stopped U.S. shipment of IOLs and was considering a humanitarian device exemption. However, the company did not provide the results of its HDE consideration, the letter notes.
It also raps the company for failing to include the location of design documents, and information on changes made to its lenses, in its design history file. Further, its complaint handling procedure did not detail how it will evaluate complaints for Medical Device Reporting.
Advanced Vision Science did not respond to a request for comment by press time.
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