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

• Date Initiated by Firm: June 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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