FDA Warns Surgin Against Sale of Generic Blades for Moria Keratomes.

Medical, Health & Legal Writers

DOYLESTOWN, Penn.--(BW HealthWire)--Oct. 5, 2001

Officials of the Federal Food and Drug Administration (FDA) have determined that Surgin, Inc. does not have legal authority to sell replacement blades for use with microkeratomes manufactured by Moria, S.A. The FDA's Office of Compliance and Office of Device Evaluation, Center for Devices and Radiological Health issued their determination after Moria raised concerns with the agency that Surgin was marketing its blades for use with Moria's microkeratomes without proper approval. Moria manufactures and sells microkeratomes, machines that use a thin blade to create the corneal flap during LASIK refractive surgery. Surgin manufactures and sells blades it claims can be used with Moria's microkeratomes.

Moria brought this matter to the FDA's attention in a letter to the agency dated April 12, 2001. The FDA sent Surgin a letter dated April 23, 2001, in which the agency informed Surgin that:

"Your web page(s) . . . incorrectly indicate that the prizm blade

may be used interchangeably with that of other competing

manufacturers. For example, your web page . . . promotes

Surgin microkeratome blades for use with microkeratomes made

by Moria, Incorporated . . . and SCMD. Additionally, your

'competitor' page contains the claim, 'Surgin has the right to

freely manufacture and sell disposable lasik blades as

products used in conjunction with the microkeratomes of

others.' The agency disagrees with this opinion." (Emphasis

added.)

The agency's letter continues:

"Surgin's clearance for the Accublade is specifically limited for

use in conjunction with the Chiron microkeratome. . . . Surgin

may not promote or sell the Prizm blade during the pendency of

your 510(k) submission for use in microkeratomes for which the

blades have not received clearance, because doing so would

misbrand your other legally marketed devices that are already

offered for sale." (Emphasis added.)

In a follow-up letter to Surgin dated June 27, 2001, the FDA said that Surgin "erred" in determining that it did not need separate FDA approval for its Prizm(TM) blades and that

"a new 510(k) submission is required because a change in blade

shape raises new issues of safety and effectiveness and

requires design validation. Each keratome has significantly

different specifications for the blade requiring validation

testing for each different type of keratome replacement blade.

An incorrect fit in the keratome may cause serious adverse

events such as an uneven cut (resulting from blade chatter), a

too shallow cut ('button-hole'), a too deep cut (corneal

perforation), or a free flap."

The agency reiterated in its June 27 letter that Surgin may not legally continue to promote Surgin blades for use with keratomes of other manufacturers besides Chiron.

Moria obtained copies of the FDA's correspondence with Surgin through a Freedom of Information Act request. In addition to lodging a complaint with the agency, Moria has filed suit against Surgin in federal district court in Virginia. Moria's complaint alleges that Surgin has engaged in false and misleading advertising in violation of the federal Lanham Act. In particular, Moria's complaint asserts that Surgin's website advertising incorrectly states that Surgin has received 510(k) clearance from the FDA to market its Prizm(TM) line of blades, including the blades intended for use with Moria's microkeratomes, and Moria alleges that Surgin in fact has not received 510(k) approval for those blades. The FDA correspondence confirms that the allegations of Moria's complaint are correct.

After the complaint was filed, Surgin altered its website to remove the statement that it has received FDA clearance for the Prizm(TM) blades. However, Moria has received reports that even after receiving warning letters from the FDA, Surgin is still telling its prospective customers that these blades have FDA approval for use with Moria's microkeratomes.

"We are more concerned than ever about the promotion and sale of Surgin's blades for use with our microkeratomes," said Alain Duprat, President and CEO of Moria. "The FDA has clearly ruled that Surgin must have separate 510(k) approval to market or sell its blades for use with our machines," Duprat continued. "Surgin does not have this approval. Therefore, there is no assurance that Surgin's blades are safe and effective for use with Moria's microkeratomes," said Duprat. "Any attempt by Surgin to sell its unapproved blades to Moria customers is both unlawful and threatens patient safety," Duprat said.

Moria does not warrant the use of its microkeratomes with unapproved replacement blades and disclaims any responsibility for any liability incurred by its customers as a result of using Moria microkeratomes with blades that have not been approved by the FDA.

Moria is a publicly traded medical device manufacturer, headquartered in Antony, France, specialized in ophthalmic surgical instrumentation. The U.S. subsidiary, Moria, Inc., is headquartered in Doylestown, PA.