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U.S. Department of Health and Human Services

Class 1 Device Recall Visulas 532 s with Visulink 532/U

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  Class 1 Device Recall Visulas 532 s with Visulink 532/U see related information
Date Initiated by Firm June 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 11, 2005
Recall Number Z-1066-04
Recall Event ID 29367
510(K)Number K013402  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
Code Information serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935
Recalling Firm/
Manufacturer		 Carl Zeiss Ophthalmic Systems Inc
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact R. Michael Crompton
925-557-4353
Manufacturer Reason
for Recall		 The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result.
FDA Determined
Cause 2		 Other
Action On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.
Quantity in Commerce 20
Distribution The product was distributed directly to health professionals or hospitals.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CARL ZEISS, INC.
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