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Medical Devices

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

The following document is a copy of a Press Release from Carl Zeiss Meditec Inc. related to the Class I Medical Device Recall of the Carl Zeiss Ophthalmic System-VISULAS 532s with VISULINK 532/U.  See the nearby link to the recall notice.

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

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.

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