Z-1664-2010

Bausch & Lomb Stellaris Vision Enhancement System

Name: Z-1664-2010 Bausch & Lomb Stellaris Vision Enhancement System
Creator: Bausch & Lomb Inc
Published: 2010-01-15
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2010-01-15 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Stellaris Vision Enhancement System on 2010-01-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1664-2010
Status: Terminated
Initiated: 2010-01-15
Posted: 2010-05-26
Terminated: 2013-05-17
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Stellaris Vision Enhancement System.
Product code: NFJ System, Image Management, Ophthalmic
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: All devices manufactured since 2004

Product code NFJ

K063331Class IIBausch & Lomb Ngx Microsurgical SystemBausch & Lomb, Inc. / cleared 2006-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)