UPDATE: Alcon Voluntary Recall in Japan of ReSTOR® and ReSTOR® Toric Multifocal Intraocular Lenses
Aug 19, 2015
Issue isolated to Japan; does not affect Alcon IOLs sold throughout rest of world
Fort Worth, Texas, USA – August 19, 2015 – Alcon, the global leader in eye care and a division of Novartis, has completed its voluntary recall of ReSTOR® and ReSTOR® Toric multifocal intraocular lenses (IOLs) previously sold in Japan. All ReSTOR® and ReSTOR® Toric multifocal IOLs have been removed from the Japanese market and are not currently available for use within the country.
The recall did not affect other Alcon IOLs sold in Japan, nor did it affect any IOLs (including ReSTOR and ReSTOR Toric multifocal IOLs) available throughout the rest of world. The manufacturing process for the Japan ReSTOR and ReSTOR Toric multifocal IOLs differs from that used to manufacture IOLs for other markets. As a result of this different manufacturing process, the IOLs manufactured for the Japan market have different surface properties than IOLs manufacutered for other markets. Alcon has extensively reviewed its global safety vigilance data for all AcrySof® IOLs distributed outside of Japan and to date has not identified any safety signal relating to the IOLs distributed outside of Japan.
To date, the patients in Japan who developed post-operative inflammation following cataract surgery are being treated and monitored. No cases of permanent vision loss were reported.
Alcon has conducted a thorough medical safety and manufacturing investigation with the help of leading experts in ophthalmology. Alcon has also worked closely with all relevant regulatory authorities. In Japan, Alcon is working with the Pharmaceutical and Medical Devices Agency of Japan (PMDA), the Japan Ministry of Health, Labor and Welfare (MHLW), and the Tokyo Metropolitan Government (TMG) on its manufacturing and medical safety investigation. In July 2015, Alcon communicated with PMDA and MHLW regarding the changes that will be made to the manufacturing process prior to reintroducing ReSTOR and ReSTOR Toric multifocal IOLs in Japan.
On August 7, 2015 the U.S. Food and Drug Administration (FDA) designated the voluntary recall in Japan as a Class I recall. The FDA recall is limited to the ReSTOR and ReSTOR Toric multifocal IOLs distributed only within the Japan market.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people see better. Alcon’s three businesses, Surgical, Pharmaceutical and Vision Care, offer the widest spectrum of eye care products in the world. Alcon is a division of the Novartis Group, with pro-forma sales of USD 10.8 billion in 2014. Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, please visit www.alcon.com.