Eyeworld

EW NEWS & OPINION 5 if you take every innovator and con- sultant off the podium." The med tech industry shipped $1.23 billion in products outside the U.S. last year, he said. "It's one of the few industries in America that has a positive balance of trade. It pays $21.5 billion in salaries and employs more than 357,000 peo- ple." Until the late 1990s, venture capitalists weren't heavily involved in ophthalmology, he added. Since 1999, however, they've invested in more than 47 ophthalmic start-ups. Yet a Stanford University Study found "unpredictable, inefficient, and expensive regulatory processes are jeopardizing America's leader- ship position in med tech innova- tion," Dr. Lindstrom said. The cost to bring new products to market has grown exponentially, to about $40 billion for 20 new drugs. In 10 years, "we will be spending $80 billion to bring zero products to market." Compounding the issue is the length of time and money it takes to bring a product to market in the U.S. compared with Europe, he said. "To get something approved under a 510(k) in the U.S. is almost 4 years," Dr. Lindstrom said. "In Eu- rope, it's 7 months. I don't think people in Europe are any less safe than they are here. To get something that requires a PMA is in the range of 5 years here compared to 11 months in Europe." European regu- lators are viewed as more reasonable, more predictable, more transparent, "and better overall than their U.S. counterparts," which means more companies are leaving the U.S. to conduct studies abroad, he said. "Once we start exporting inno- vation jobs, these jobs won't come back," he said. EW Editors' note: Dr. Bille has financial in- terests with Aaren Scientific (Ontario, Calif.) and Heidelberg Engineering (Heidelberg, Germany). Dr. Edelhauser has financial interests with Alcon (Fort Worth, Texas), GlaxoSmithKline (Lon- don), and LensAR (Winter Park, Fla.). Dr. Fabian has financial interests with Abbott Medical Optics (Santa Ana, Calif.) and Zeiss Certified (Jena, Ger- many). Dr. Falkenstein has no financial interests related to his comments. Dr. Kaufman has a financial interest with Rapid Pathogen Screening (Sarasota, Fla.). Dr. Lindstrom consults for numer- ous companies involved with ophthal- mology and is an investor in several start-up companies. Dr. Olson has a financial interest with Advanced Re- fractive Technologies (San Clemente, Calif.). Dr. Peyman has no financial interests related to his comments. Contact information Lindstrom: rllindstrom@mneye.com Important Safety Information – Tecnis ® Multifocal IOL Caution: Federal law restricts this device to sale by or on the order of a physician. Indications: Tecnis ® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Precautions: The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long-term effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or over 45°C. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration. Adverse events: The most frequently reported adverse event that occurred during the clinical trial of the Tecnis ® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3-1.2% of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction). Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. 2011.02.08-CT2955 June 2011

• Cover