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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter

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 Class 2 Device Recall Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cuttersee related information
Date Initiated by FirmFebruary 09, 2007
Date PostedApril 21, 2007
Recall Status1 Terminated 3 on April 07, 2009
Recall NumberZ-0765-2007
Recall Event ID 37281
510(K)NumberK980488 
Product Classification Vitrectomy Cutter - Product Code HQE
ProductBausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
Code Information All lots
FEI Number 1317628
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information ContactDouglas J. Fortunato
585-338-5477
Manufacturer Reason
for Recall		The cutter probe tip breaks during use.
FDA Determined
Cause 2		Other
ActionOn 2/12/07, express mail letters were addressed to operating room supervisors to notify them of the recall. Additional E-mail notifications were issued on 2/14/07 to doctors and letters were addressed to them on 2/20/07 to make them aware of the recall, although they do not directly receive the product. The communications instructed them to not use the affected product and to return it, along with the business reply card.
Quantity in Commerce32,190 units of Catalog No: CX 5825
DistributionClass II Recall - Worldwide Distribution --- USA including states of MO, NC, FL, CA, and TX and countries of Canada, China, Japan, Australia, Hong Kong, India, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands
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 = HQE
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