FDA Statement美國食品暨藥物管理局（FDA）公報 【中英文版】
FDA-Requested Recall - Cytosol Laboratories, Inc.
Product Contains Dangerous Levels of Endotoxin
美國食品暨藥物管理局（FDA）要求視妥多眼科公司（Cystosol Laboratories, Inc.）全面回收平衡鹽溶液－產品成份內含危險標準之內毒素
The U.S. Food and Drug Administration (FDA) today delivered a letter to Cytosol Laboratories, Inc., of Braintree, Mass., to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. BSS is a drug used by health professionals to irrigate a patient’s eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery.
美國食品暨藥物管理局（後稱美國FDA）日前（2月13日）去函要求視妥多眼科公司（Cytosol Laboratories, Inc.，後稱視妥多公司），全面回收旗下工廠生產所有包裝之視妥多平衡鹽溶液（Cytosol BSS，Balanced Salt Solution）。平衡鹽溶液為藥用之灌注溶液，廣泛用於眼、耳、鼻、喉各科之手術，包括眼科的白內障手術。
FDA requested the recall because product lots were found to have elevated levels of endotoxin. Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome(TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories, Inc.
美國FDA要求回收的原因為該產品被發現成份中含有內毒素，內毒素亦稱為致熱物（Pyrogens），已被證實將會導致如發燒、休克、血壓改變及其他循環功能之嚴重的後果。美國FDA接獲報告指出：諸如內毒素等因污染產生的物質，在眼科手術時進入眼球前房時會產生激烈的反應，十分有可能造成眼前房的毒性反應（TASS，Toxic Anterior Segment Syndrome）；美國 FDA 並收到超過300名病患因使用視妥多公司所生產的平衡鹽溶液而產生相關傷害的抱怨。
The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals. An FDA-requested recall is initiated to protect the public health when a product that has been distributed represents a risk of illness or injury and the firm has not initiated a recall of the product. FDA is instructing hospitals, physicians, and consumers to immediately stop using any of these products, quarantine any remaining product, and if no return instructions from Cytosol are received, destroy the product.
美國FDA已要求該公司立即回收平衡鹽溶液所有庫存品，包括已發貨給醫療院所之庫存。美國FDA回收令發佈時機為當有發現產品有違民眾健康風險且生產商尚未開始回收產品。美國FDA並命令醫療院所、技術員及消費大眾立即停止使用視妥多公司平衡鹽溶液並妥當保管現有庫存品，若視妥多公司未盡回收之責時，應銷毀庫存品。
An estimated one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:
據估計約有從2003年12月至2005年12月間約1百萬單位之Cytosol BSS產品被銷售，而BSS產品被要求回收的為視妥多眼科公司（Cytosol Laboratories, Inc.）所製造的，共有下列三種經銷標籤：
"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.
"AMO Endosol" 由Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.所經銷
"Cytosol Ophthalmics"由Cytosol Ophthalmics, Lenoir, NC;所經銷
"Akorn"由 Akorn, Inc., Buffalo Grove, Ill.所經銷
國內衛生署藥政處也已通知國內醫療院所暫停使用該項產品，目前，被要求回收的灌洗液僅限視妥多產品，和其他公司生產的同成分的眼用溶液（Generic BSS）無關。因此病患與家屬無須憂慮，只要在進行眼科或耳、鼻等手術時，注意一下就醫的醫療院所使用的灌洗液品牌即可。
愛爾康藥廠手術用品暨儀器事業處產品經理孫小玲表示，此次引發大眾疑慮的主角─灌洗液係屬醫療專用藥品，常用於眼睛、耳朵、鼻部或喉嚨作各種手術過程中的灌洗，一般稱為眼科均衡鹽溶液（Balanced Salt Solution，簡稱BSS），目前所有藥廠所製造的眼用灌注液，一般通稱為BSS，再冠上各自藥廠名稱（如愛爾康BSS）。
孫小玲強調，BSS係屬滅菌生理均衡鹽溶液，含有正常細胞代謝所必須的離子，必須由醫師處方使用，由於該產品完全不含防腐劑，需保存於真空無菌狀態，因此，在生產過程中要格外謹慎小心，以免遭到污染。他建議民眾勿因某單一品牌產品出問題而對於眼科就醫裹足不前，可於手術進行前再次確認所就醫的醫療院所使用的手術灌洗液為合格並有專業品質保證的均衡鹽溶液。
FDA-Requested Recall - Cytosol Laboratories, Inc.
Product Contains Dangerous Levels of Endotoxin
美國食品暨藥物管理局（FDA）要求視妥多眼科公司（Cystosol Laboratories, Inc.）全面回收平衡鹽溶液－產品成份內含危險標準之內毒素
The U.S. Food and Drug Administration (FDA) today delivered a letter to Cytosol Laboratories, Inc., of Braintree, Mass., to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. BSS is a drug used by health professionals to irrigate a patient’s eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery.
美國食品暨藥物管理局（後稱美國FDA）日前（2月13日）去函要求視妥多眼科公司（Cytosol Laboratories, Inc.，後稱視妥多公司），全面回收旗下工廠生產所有包裝之視妥多平衡鹽溶液（Cytosol BSS，Balanced Salt Solution）。平衡鹽溶液為藥用之灌注溶液，廣泛用於眼、耳、鼻、喉各科之手術，包括眼科的白內障手術。
FDA requested the recall because product lots were found to have elevated levels of endotoxin. Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome(TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories, Inc.
美國FDA要求回收的原因為該產品被發現成份中含有內毒素，內毒素亦稱為致熱物（Pyrogens），已被證實將會導致如發燒、休克、血壓改變及其他循環功能之嚴重的後果。美國FDA接獲報告指出：諸如內毒素等因污染產生的物質，在眼科手術時進入眼球前房時會產生激烈的反應，十分有可能造成眼前房的毒性反應（TASS，Toxic Anterior Segment Syndrome）；美國 FDA 並收到超過300名病患因使用視妥多公司所生產的平衡鹽溶液而產生相關傷害的抱怨。
The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals. An FDA-requested recall is initiated to protect the public health when a product that has been distributed represents a risk of illness or injury and the firm has not initiated a recall of the product. FDA is instructing hospitals, physicians, and consumers to immediately stop using any of these products, quarantine any remaining product, and if no return instructions from Cytosol are received, destroy the product.
美國FDA已要求該公司立即回收平衡鹽溶液所有庫存品，包括已發貨給醫療院所之庫存。美國FDA回收令發佈時機為當有發現產品有違民眾健康風險且生產商尚未開始回收產品。美國FDA並命令醫療院所、技術員及消費大眾立即停止使用視妥多公司平衡鹽溶液並妥當保管現有庫存品，若視妥多公司未盡回收之責時，應銷毀庫存品。
An estimated one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:
據估計約有從2003年12月至2005年12月間約1百萬單位之Cytosol BSS產品被銷售，而BSS產品被要求回收的為視妥多眼科公司（Cytosol Laboratories, Inc.）所製造的，共有下列三種經銷標籤：
"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.
"AMO Endosol" 由Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.所經銷
"Cytosol Ophthalmics"由Cytosol Ophthalmics, Lenoir, NC;所經銷
"Akorn"由 Akorn, Inc., Buffalo Grove, Ill.所經銷
國內衛生署藥政處也已通知國內醫療院所暫停使用該項產品，目前，被要求回收的灌洗液僅限視妥多產品，和其他公司生產的同成分的眼用溶液（Generic BSS）無關。因此病患與家屬無須憂慮，只要在進行眼科或耳、鼻等手術時，注意一下就醫的醫療院所使用的灌洗液品牌即可。
愛爾康藥廠手術用品暨儀器事業處產品經理孫小玲表示，此次引發大眾疑慮的主角─灌洗液係屬醫療專用藥品，常用於眼睛、耳朵、鼻部或喉嚨作各種手術過程中的灌洗，一般稱為眼科均衡鹽溶液（Balanced Salt Solution，簡稱BSS），目前所有藥廠所製造的眼用灌注液，一般通稱為BSS，再冠上各自藥廠名稱（如愛爾康BSS）。
孫小玲強調，BSS係屬滅菌生理均衡鹽溶液，含有正常細胞代謝所必須的離子，必須由醫師處方使用，由於該產品完全不含防腐劑，需保存於真空無菌狀態，因此，在生產過程中要格外謹慎小心，以免遭到污染。他建議民眾勿因某單一品牌產品出問題而對於眼科就醫裹足不前，可於手術進行前再次確認所就醫的醫療院所使用的手術灌洗液為合格並有專業品質保證的均衡鹽溶液。
