爱尔康主动召回仅在日本销售的AcrySof® Toric产品线高度数 人工晶体
 
   此次主动召回并不影响爱尔康在日本以外市场所销售的任何人工晶体
   2015年4月，诺华公司旗下全球眼科及视力保健领域领导者爱尔康宣布：主动在日本市场召回ReSTOR® 以及ReSTOR® Toric 多焦点人工晶体产品，同年10月，爱尔康主动在日本市场召回AcrySof® Toric 产品线内的高度数人工晶体产品并完成了所有问题产品的召回。爱尔康主动召回的产品仅供日本市场，因而召回不会波及日本以外的人工晶体产品。

 

英文原文：

Alcon voluntarily recalls high-cylinder intraocular lenses within the AcrySof® Toric line sold in Japan

 

Fort Worth, Texas, USA - October 2, 2015 – Alcon, the global leader in eye care and a division of Novartis, has elected to voluntarily recall high-cylinder intraocular lenses (IOLs) within the AcrySof® Toric line in Japan, following a voluntary recall of its ReSTOR® and ReSTOR® Toric multifocal IOLs in Japan in April 2015. This voluntary recall does not affect any IOLs outside of Japan, nor does it affect Alcon’s monofocal and low-cylinder toric IOLs sold in Japan.
 
Alcon decided to voluntarily recall its high-cylinder lenses within the AcrySof Toric line in Japan in the interest of patient safety based on an increased number of cases of post-operative inflammation reported following cataract surgery in various clinics in Japan. Alcon is working with clinics in Japan to ensure affected patients are being treated and monitored. No cases of permanent vision loss have been reported.
 
The manufacturing process for Alcon IOLs manufactured for Japan differs from that used to manufacture IOLs for the rest of the world. Specifically, all IOLs manufactured for Japan undergo a different curing process compared to IOLs manufactured for other markets.  As a result, the IOLs manufactured for Japan have different surface properties.
 
Alcon has conducted a thorough investigation with the help of leading experts in ophthalmology.  The investigation has determined that the increase in cases of post-operative inflammation in Japan is correlated to a combination of the unique surface properties of the Japan IOLs and common processing steps that are used only for AcrySof ReSTOR, ReSTOR Toric, and high-cylinder Toric IOLs (SNA6T6-SNA6T9). Alcon has already identified and is implementing process improvements to prevent  recurrence of this issue.
 
No other Alcon IOLs sold in Japan or any IOLs available throughout the rest of the world are affected by this expanded voluntary recall. Alcon is communicating with relevant regulatory authorities globally, including Japan regulatory authorities (MHLW and PMDA) as well as the U.S. Food and Drug Administration (FDA) regarding this expanded market action in Japan and our proposed manufacturing process improvements.  

 

原文链接：http://www.alcon.com/news-center/news-item.aspx?id=380

 

 

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