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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Millenium Phacoemulsification Needle, Frag 15 Degree

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 Class 2 Device Recall Bausch & Lomb Millenium Phacoemulsification Needle, Frag 15 Degreesee related information
Date Initiated by FirmMarch 26, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on January 21, 2010
Recall NumberZ-2051-2008
Recall Event ID 47422
510(K)NumberK041998 
Product Classification Reprocessed phacoemulsification needle - Product Code NKX
ProductBausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS 1600A, 6 needles per pouch, nonsterile.
Code Information Lot number 3171341
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information ContactMike Judy
949-389-3601
Manufacturer Reason
for Recall		The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
FDA Determined
Cause 2		Labeling Change Control
ActionThe recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned. If you have questions, contact Customer Service at 1-800-338-2020.
Quantity in CommerceTotal of all sizes - 4,055/6-needle packages
DistributionDistribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Thailand, Turkey, and United Arab Emerites.
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 = NKX
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