Class I Medical Device Recalls - Carl Zeiss Meditec Ophthalmic System

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Medical Device Recalls
Class I Recall: Carl Zeiss Meditec Ophthalmic System

Date Recall Initiated	June 3, 2004
Product:	Carl Zeiss Ophthalmic System – VISULAS 532s with VISULINK 532/U surgical laser instrument.
Use:	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.
Recalling Firm:	Carl Zeiss Meditec 5160 Hacienda Drive Dublin, California 94568-7562
Reason for Recall:	A mirror is used to direct the laser treatment beam to the patient’s eye. The coating of the reflective mirror of the VISULINK 532/U could tear and loosen from the mirror surface.
Public Contact:	Carl Zeiss Meditec Customer Service 800-341-6968
FDA District:	San Francisco
FDA Comment:	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. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
	For additional information on this product recall, see the Carl Zeiss Meditec press release at: http://www.fda.gov/cdrh/recalls/recall-060304-pressrelease.html Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00856.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".

Updated July 30, 2004

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