Description of Event or Problem · 1
CO'S ADVERTISEMENT CONTAINS SEVERAL EFFICACY CLAIM VIOLATIONS. 1) "CO HAS DEVELOPED A SURGICAL SYSTEM SPECIFICALLY CONCEIVED AND DESIGNED TO PRODUCE UNRIVALED RESULTS IN CORNEAL REFRACTIVE SURGERY." 2) ON THE SECOND PAGE IN THE FIRST PARAGRAPH, THERE IS A STATEMENT THAT READS, "WITH THE SURGICAL SYSTEM, THE COMPUTER-CONTROLLED SURGICAL BEAM WILL PERFORM A PRESCRIBED PROCEDURE ACCURATELY WITH NO UNCERTAINTY." 3) IN THE SECOND PARAGRAPH ON THE THIRD PAGE READS: "THE LASER SURGERY SYSTEM DRAMATICALLY REDUCES THE ACOUSTIC TRAUMA DURING SURFACE ABLATION AND CREATES A SMOOTHER POSTOPERATIVE CORNEAL SURFACE. THEREFORE, IT IS REASONABLE TO EXPECT THAT HEALING TIME AND POSTOPERATIVE DRUG TREATMENT MAY BE REDUCED." 4) THE FOURTH PARAGRAPH ON THE THIRD PAGE READS: "THE TECHNOLOGY ALSO ALLOWS THE SURGEON TO PERFORM INTRASTROMAL CAVITATION PROCEDURES WITH INCREASED ACCURACY AND PRECISION. FURTHER, CO IS DEVELOPING A LASER MICROKERATOME THAT WILL PROVIDE MORE PRECISION AND REFINEMENT TO LAMELLAR REFRACTIVE SURGERY." 5) ON PAGE FOUR IN PARAGRAPH TWO READS THE FOLLOWING: "MANY PHYSICIANS HAVE CONCLUDED THAT THE BEST WAY TO ACHIEVE THAT OBJECTIVE IS TO INVEST IN TECHNOLOGY THAT WILL PAY FOR ITSELF QUICKLY AND ENABLE THEM TO PERFORM PROCEDURES IN LESS TIME WITH GREATER ACCURACY." LASTLY, AT THE BOTTOM OF PAGE FOUR THE AD INVITES PHYSICIANS TO JOIN IN THEIR CLINICAL TRIALS BUT MAKES NO DISCLAIMER STATEMENT THAT THE LASER SYSTEM IS LIMITED BY LAW TO INVESTIGATIONAL USE.