Laser Vision Centers, Inc.
This article was originally published in The Gray Sheet
Provider of laser vision correction equipment and support services is served with an administrative complaint and notice of opportunity for hearing by FDA's Center for Devices and Radiological Health relating to a March 1998 subpoena, LVC announces April 20. FDA action under administrative civil monetary procedures, launched April 4, proposes to assess civil monetary penalties totaling $5 mil. ($1 mil. for the company and each of four involved executives) for actions considered to have adulterated the devices. FDA's complaint relates to the company's use of "international" or "Bermuda cards" - electronic key card software enabling the use of the firm's excimer lasers to treat myopia cases beyond the range of FDA approval (greater than -6 diopters) prior to 1998. The company maintains that neither LVC nor other U.S. users of excimer lasers have used the cards since early 1998. Accordingly, LVC does not expect the action to have a material impact on the company. In 1996, the agency compelled Visx to modify software in its Star laser system so surgeons could not perform photorefractive keratectomy procedures on high myopia or astigmatism patients. Visx denies any knowledge of FDA's current actions
You may also be interested in...
A package of health proposals intended to build up the EU’s resilience to health threats while strengthening the competitiveness of Europe’s pharmaceutical industry and ensuring access to affordable drugs takes a major step through the legislative process this week.
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.
The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.