Alcon announces a voluntary product recall in Japan
Apr 14, 2015
Fort Worth, Texas, April 14, 2015 – On April 14, 2015, Alcon announced a voluntary product recall in Japan for all ReSTOR® and ReSTOR® Toric multifocal intraocular lenses (IOLs) manufactured specifically for the Japan market. Alcon elected to voluntarily conduct this recall out of high caution and in the interest of patient safety due to an increased number of aseptic endophthalmitis cases reported with the use of these IOLs in various clinics in Japan from mid-January this year.
There has been no increase in reports of aseptic endophthalmitis with any other Alcon IOLs in Japan, nor with any Alcon IOLs outside of Japan. This voluntary product recall does not affect other Alcon IOLs sold in Japan, nor does it affect any IOLs (including ReSTOR® and ReSTOR® Toric multifocal IOLs) available outside of Japan.
To date, Alcon’s internal investigation of the manufacturing process has not identified any root causes that could potentially be attributed to the reports of aseptic endophthalmitis in Japan. The manufacturing process for the Japan ReSTOR® and ReSTOR® Toric multifocal IOLs differs from the process used to manufacture IOLs for other markets in that IOLs manufactured for Japan undergo a process that addresses curing and drying requirements that are specific to the Japan market.
Alcon is working closely with all relevant regulatory authorities in Japan, including the Pharmaceutical and Medical Devices Agency of Japan (PMDA), the Japan Ministry of Health, Labor and Welfare (MHLW), and the Tokyo Metropolitan Government (TMG). In addition, we have informed regulatory authorities in other markets around the world of this voluntary recall, in compliance with legal and regulatory requirements.
Alcon is fully committed to ensuring the safety of its products, and to conducting a full and thorough investigation of the reported cases of aseptic endophthalmitis. We are partnering with leading ophthalmologists with expertise in ocular inflammation and cataract surgery from Japan and around the world to assist in our ongoing medical safety and manufacturing investigation.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. Alcon’s three businesses, Surgical, Pharmaceutical and Vision Care, offer the widest spectrum of eye care products in the world. Alcon is the second largest 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, visit www.alcon.com.
Elizabeth Harness Murphy Director, Global External Communications +1-585-435-7379 (mobile) [email protected]