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Class 2 Device Recall Bausch & Lomb Lightning High Speed Vitrectomy Cutter |
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Date Initiated by Firm |
December 14, 2006 |
Date Posted |
May 24, 2007 |
Recall Status1 |
Terminated 3 on April 07, 2009 |
Recall Number |
Z-0495-2007 |
Recall Event ID |
36980 |
510(K)Number |
K980488
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Product Classification |
Vitrectomy Cutter - Product Code HQE
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Product |
Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. 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
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Manufacturer Reason for Recall |
The cutter tip could break during a procedure
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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. CX4804 - 3,485 Cutter Tips |
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 and Original Applicant = STORZ INSTRUMENT CO.
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