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U.S. Department of Health and Human Services

Medical Devices

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Carl Zeiss Meditec Ophthalmic System

Class I Recall
Date Recall
Initiated:
June 3, 2004
Product:
Carl Zeiss Meditec 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 nearby link.