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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110

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  Class 2 Device Recall Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110 see related information
Date Initiated by Firm July 27, 2011
Date Posted August 30, 2011
Recall Status1 Terminated 3 on June 21, 2013
Recall Number Z-3087-2011
Recall Event ID 59662
510(K)Number K082473  
Product Classification Phacofragmentationn Unit - Product Code HQC
Product Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile.
Bausch & Lomb Incorporated,
Rochester, NY

For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
Code Information Model # BL5110, CaLot #U6480,  Exp. 11/2012
Recalling Firm/
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Joseph Tsai
Manufacturer Reason
for Recall
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
FDA Determined
Cause 2
Nonconforming Material/Component
Action Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
Quantity in Commerce 9/6-unit cases
Distribution Nationwide Distribution.
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 = HQC and Original Applicant = BAUSCH & LOMB, INC.