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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack

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  Class 2 Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack see related information
Date Initiated by Firm December 14, 2006
Date Posted May 24, 2007
Recall Status1 Terminated 3 on April 07, 2009
Recall Number Z-0496-2007
Recall Event ID 36980
510(K)Number K980488  
Product Classification Vitrectomy Cutter - Product Code HQE
Product Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
Code Information All lots
Recalling Firm/
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Douglas J. Fortunato
Manufacturer Reason
for Recall
The cutter tip could break during a procedure
FDA Determined
Cause 2
Action Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.
Quantity in Commerce Cat. CX4920 - 4,475 packs; and Cat. CX4920A - 40 packs
Distribution Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands.
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 = HQE and Original Applicant = STORZ INSTRUMENT CO.