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U.S. Department of Health and Human Services

Safety

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Carl Zeiss Ophthalmic System

Audience: Ophthalmologists, operating room supervisory personnel, and risk managers

FDA and Carl Zeiss Meditec notified healthcare professionals of a Class I recall of one lot of VISULINK 532/U that may contain a defective mirror coating. This medical device is intended for use in laser treatment of diseases of the eye, particularly in treating retinal detachments or bleeding of the retina. The faulty mirror may misdirect the laser beam to an unintended target in or on the eye resulting in retinal bleeding and/or burns due to excessive laser energy in the eye.

[July 9, 2004 Recall Notice - FDA]
[July 9, 2004 Press Release - FDA]