Bausch & Lomb Permanently Removes ReNu With MoistureLoc Product Worldwide博士倫永久刪除的Renu與moistureloc產品在全球
According to US drug regulator FDA, contact lens maker Bausch & Lomb has finally decided to permanently withdraw its lens solution "ReNu with MoistureLoc" from global market after more evidence linked it with Fusarium infection in eye.根據美國藥物監管機構美國食品藥品管理局,接觸鏡製造商博士倫終於決定永久撤回其鏡頭的解決方案“的Renu與moistureloc ”從全球市場後,更多的證據聯繫起來,與鐮刀菌感染的眼睛。
Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.博士倫提出了這一獨特的特點,制訂有關的Renu與moistureloc產品在某些特殊情況下可以增加的風險,鐮刀菌感染。
Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium.在此基礎上的科學和流行病學數據表明的Renu與moistureloc可能會增加易感性的枯萎。
As part of the joint Center for Disease Control & Prevention (CDC) and FDA investigation, field officers have been inspecting the Bausch & Lomb plant and facilities in Greenville , SC since March 22, 2006 .作為部分的聯合中心,疾病控制和預防(議會)和FDA調查後,外勤人員已檢查博士倫工廠和設施,在格林維爾,資深大律師,自2006年3月22日。 While the plant inspection is being finalized, there is still some additional testing to be completed.而植物檢驗正在最後敲定,還有一些額外的測試才能完成。 The agency plans to issue observations from the inspections imminently.該機構計劃發行的意見,從檢查即將。
Since June 2005, more than 120 people across the United States were infected with Fusarium keratitis.自2005年6月,已有超過120人,美國各地的人感染鐮刀黴角膜炎。 Most confirmed cases have been associated with the Bausch & Lomb solution, FDA said.最證實個案已與博士倫的解決辦法, FDA說。
Fusarium is a fungus typically found in plants and soil in tropical and subtropical areas.鐮刀菌是一種真菌通常是在植物中發現和土壤在熱帶和亞熱帶地區。 The infection can last several months without treatment, and can scar the cornea and cause blindness.感染可以持續數月沒有接受治療,並能瘢痕角膜造成失明。
Eight patients in the US have reportedly undergone cornea transplant surgery after the fungal eye infection. 8病人,在美國據報導,經歷了角膜移植手術後,眼睛真菌感染。 Several patients are suing the company.幾個病人控告該公司。
The fungal eye infection outbreak was also reported in Singapore, Malaysia and Hong Kong from 2005 to February of this year.真菌眼睛感染爆發另據報導,在新加坡,馬來西亞和香港,從2005年到今年二月。 Health officials discovered that almost 40 Asian cases were linked to contact lens users.衛生官員發現,近40亞洲案件有聯繫接觸透鏡的用戶。
Source: FDA資料來源:美國FDA
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