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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Millenium Phacoemulsification Needle, Tapered Hub 45 Degree

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  Class 2 Device Recall Bausch & Lomb Millenium Phacoemulsification Needle, Tapered Hub 45 Degree see related information
Date Initiated by Firm March 26, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on January 21, 2010
Recall Number Z-2046-2008
Recall Event ID 47422
510(K)Number K041998  
Product Classification Reprocessed phacoemulsification needle - Product Code NKX
Product Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45 Degree, REF DP8145, 6 needles per pouch, nonsterile.
Code Information Lot numbers 3169597, 3170626, 3171091, 3171345, 3171567, 3171819, 3172014, 3172111, 3172320, 3172619
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Mike 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
Action The 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 Commerce Total of all sizes - 4,055/6-needle packages
Distribution Distribution 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 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 = NKX and Original Applicant = BAUSCH & LOMB, INC.
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