Bausch & Lomb Stellaris Vision Enhancement System.

FDA device recall Z-1664-2010 · posted 2010-05-26 · Terminated

Recall details

Recalling firm

Bausch & Lomb Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NFJ

Quantity affected

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.

Date initiated

2010-01-15

Date posted

2010-05-26

Date terminated

2013-05-17

Location

Rochester, NY

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