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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114

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 Class 2 Device Recall Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114see related information
Date Initiated by FirmJuly 27, 2011
Date PostedAugust 30, 2011
Recall Status1 Terminated 3 on June 21, 2013
Recall NumberZ-3090-2011
Recall Event ID 59662
510(K)NumberK082473 
Product Classification Phacofragmentationn Unit - Product Code HQC
ProductBausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, 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 # BL5114, Lot #U6482,  Exp. 11/2012.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information ContactJoseph 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
ActionBausch & 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 Commerce6/6-unit cases
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HQC
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