Class 2 Device Recall Bausch & Lomb Stellaris Vision Enhancement System

• Date Initiated by Firm: January 15, 2010
• Date Posted: May 26, 2010
• Recall Status: Terminated on May 17, 2013
• Recall Number: Z-1664-2010
• Recall Event ID: 54268
• 510(K)Number: K063331
• Product Classification: instrument, vitreous aspiration and cutting, ac-powered cord - Product Code NFJ
• Product: Bausch & Lomb Stellaris Vision Enhancement System.
• Code Information: All devices manufactured since 2004
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc; 1400 North Goodman Street; Rochester NY 14609-3547
• For Additional Information Contact: Chris Willis; 585-338-6000
• Manufacturer Reason for Recall: The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.
• Quantity in Commerce: Quantity never provided by the firm
• Distribution: Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru.
• 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 = NFJ