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FDA: Surgin cannot sell replacement blades for Moria microkeratomes
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DOYLESTOWN, Pa. — The Food and Drug Administration has determined that Surgin Inc., does not have legal authority to sell replacement blades for use with microkeratomes manufactured by Moria.
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 brought this matter to the FDA’s attention in a letter to the agency dated April 12. The FDA sent Surgin a letter dated April 23, 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.”
The agency’s letter continues:
“Surgin’s clearance for the Accu blade 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.”
In a follow-up letter to Surgin dated June 27, the FDA said that Surgin “erred” in determining that it did not need separate FDA approval for its Prizm 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, a too shallow cut, a too deep cut, 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.
Moria’s suit alleged that Surgin has engaged in false and misleading advertising in violation of the federal Lanham Act. In particular, Moria’s complaint asserted that Surgin’s Web site advertising incorrectly stated that Surgin has received 510(k) clearance from the FDA to market its Prizm line of blades, including the blades intended for use with the Moria microkeratome. Moria alleged that Surgin had not received 510(k) approval for those blades.
After the complaint was filed, Surgin altered its Web site to remove the statement that it had received FDA clearance for the Prizm blades.
Moria said it 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.