| Class 2 Device Recall Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack |  |
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
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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/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman Street Rochester NY 14609-3547
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For Additional Information Contact | Douglas J. Fortunato 585-338-5477 |
Manufacturer Reason for Recall | The cutter tip could break during a procedure |
FDA Determined Cause 2 | Other |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = HQE
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