美國加州都柏林的蔡司眼科系統公司正在召回一種眼科產品，FDA稱，召回的理由是其中一個光鏡的涂層出了問題，這種光鏡的作用是將激光引導入眼內進行治療，而光鏡上的涂層有可能發生脫落。這種有缺陷的鏡面可能造成激光指向非預定治療部位，造成視網膜出血或被燒灼。

蔡司眼科系統公司的這種產品是用于治療視網膜脫落和眼底出血的。

這種產品是帶激光手術治療裝置Visulink 532/U的Visulas 532s。

美迪醫療網將跟蹤報道此召回事件。

背景資料：

FDA披露的蔡司眼科系統公司召回函

Carl Zeiss Meditec Announces Voluntary Recall of VISULINK® 532/U

Contact:
Carl Zeiss Meditec Inc.
1- 800 - 341- 6968

DUBLIN, California (July _, 2004) -- Carl Zeiss Meditec AG (International Securities Identification Number DE000531370), today announced a voluntary recall of one lot of VISULINK® 532/U that may contain a defective mirror coating. The VISULINK 532/U is used in conjunction with the VISULAS® 532s laser, a medical device intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. No other lots of VISULINK 532/U, VISULAS 532s lasers, or other Carl Zeiss Meditec devices are involved in this action.

Recently, Carl Zeiss Meditec became aware of the potential that the coating of the reflecting mirror of the VISULINK 532/U could loosen from the surface. The reflecting mirror routes the treatment beam to the patient’s eye. Malfunction of the product could cause the laser beam to permanently damage the retina of the eye.

A total of six of the affected units were imported for distribution in the United States, three of which were introduced into commercial distribution. Carl Zeiss Meditec notified the three customers affected on June 3, 2004 to stop using the units immediately, and the units were removed for repair. The United States Food and Drug Administration (FDA) has classified this action as a Class I recall. FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. There have been no reports of injury related to this event.

Any inquiries related to this action should be addressed to Carl Zeiss Meditec Customer Service at 800-341-6968.

About Carl Zeiss Meditec

Built on an unparalleled 150-year heritage of optical innovation, Carl Zeiss Meditec AG (International Securities Identification Number DE000531370) is one of the world's leading eye care solutions providers. Its product line includes systems for the diagnosis and treatment of the four main disease groups of the eye: refraction, cataract, glaucoma and retinal disorders.

Carl Zeiss Meditec AG is based in Jena, Germany, with key subsidiaries in the U.S. (Carl Zeiss Meditec Inc.) and Japan (Carl Zeiss Meditec Limited). The rapidly aging global population and other trends are expected to grow the ophthalmic market through 2010, and the company is focused on applying innovative optical technologies to protect and enhance vision now and into the future.