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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433

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  Class 2 Device Recall Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 see related information
Date Initiated by Firm November 04, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-0863-2015
Recall Event ID 69717
510(K)Number K133486  
Product Classification Laser, ophthalmic - Product Code HQF
Product Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit)

Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
Code Information Serial numbers:  SPC00146, SPC00148, SPC00181, SPC00362, SPC00384, SPC00393, SPC00403, SPC00406, SPC00418, SPC00422, SPC00424, SPC00427, SPC00466, SPC00469, SPC00500, SPC00504, SPC00524, SPC00525, SPC00566, SPC00636, SPC00738, SPC00771, SPC00785, SPC00793, SPC00802, SPC00839, SPC00851, SPC00889, SPC00926, SPC00966, SPC00969, SPC01002, SPC01035, SPC01159, SPC01167, SPC01213, SPC01218, SPC01224, SPC01263, SPC01267, SPC01300, SPC01347, SPC01405, SPC01442, SPC01446, SPC01447, SPC01449, SPC01466, SPC01474, SPC01492, SPC01542, SPC01573, SPC01608, SPC01629, SPC01653, SPC01655, SPC01666, SPC01667, SPC01678, SPC01681, SPC01687, SPC01696, SPC01699, SPC01707, SPC01732, SPC01742, SPC01746, SPC01749, SPC01750, SPC01752, SPC01754, SPC01756, SPC01760, SPC01816, SPC01817, SPC01819, SPC01820, SPC01843 and SPC01884
Recalling Firm/
Bausch & Lomb Inc
3365 Tree Court Industrial Blvd
Saint Louis MO 63122-6615
For Additional Information Contact Glenn M. Mattei
Manufacturer Reason
for Recall
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
FDA Determined
Cause 2
Software Manufacturing/Software Deployment
Action Bausch & Lomb contacted customers by phone on November 4, 2014. Customers were informed of the conditions required for the device to malfunction. Customers were also notified that a software update to address the situation will be installed in their system within the next few weeks, and that the firm's service team will be scheduling a visit to each facility to install this software update. Customers were also told that in the meantime they may continue to use the device. For further questions please call (585) 338-6839.
Quantity in Commerce 79
Distribution Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Italy, Jordan, Malaysia, Morocco, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates.
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 = HQF and Original Applicant = BAUSCH & LOMB