愛爾康主動召回僅在日本銷售的AcrySof? Toric產(chǎn)品線高度數(shù) 人工晶體
 
   此次主動召回并不影響愛爾康在日本以外市場所銷售的任何人工晶體
   2015年4月，諾華公司旗下全球眼科及視力保健領(lǐng)域領(lǐng)導(dǎo)者愛爾康宣布：主動在日本市場召回ReSTOR? 以及ReSTOR? Toric 多焦點(diǎn)人工晶體產(chǎn)品，同年10月，愛爾康主動在日本市場召回AcrySof? Toric 產(chǎn)品線內(nèi)的高度數(shù)人工晶體產(chǎn)品并完成了所有問題產(chǎn)品的召回。愛爾康主動召回的產(chǎn)品僅供日本市場，因而召回不會波及日本以外的人工晶體產(chǎn)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.  

 

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

 

 

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