Date Initiated by Firm |
July 27, 2011 |
Date Posted |
August 30, 2011 |
Recall Status1 |
Terminated 3 on June 21, 2013 |
Recall Number |
Z-3088-2011 |
Recall Event ID |
59662 |
510(K)Number |
K082473
|
Product Classification |
Phacofragmentationn Unit - Product Code HQC
|
Product |
Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, 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 # BL5111, Lot #U6481, Exp. 11/2012. |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman Street Rochester NY 14609-3547
|
For Additional Information Contact |
Joseph Tsai 949-521-7895
|
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 |
229/6-unit cases |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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