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U.S. Department of Health and Human Services

Class 2 Device Recall Zyoptix XP Microkeratome maxon motor

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  Class 2 Device Recall Zyoptix XP Microkeratome maxon motor see related information
Date Initiated by Firm April 23, 2008
Date Posted October 22, 2008
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-0103-2009
Recall Event ID 47839
510(K)Number K040204  
Product Classification Ac-Powered Keratome - Product Code HNO
Product Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
Code Information Serial numbers: 77318901, 77318902, 77318903, 77318904, 77318905, 77318907, 77318910, 77318911, 77318913, 77318914, 77318915, 77318917, 77318918, 77318919, 77318922, 77318923, 77318924, 77318929, 77318930, 77318931, 77318932, 77504010, 77504012, 77504017, 77732304, 77732306, 77732308, 77732309, 77732310, 77732311, 77732312, 77732313, 77732314, 77732315, 77898709, 77898711, 78080303, 78080307, 78080308, 78080309, 78080310, 78080312, 78080313, 78080314, 78080315, 78080320, 78080322, 78080331, 78080337, 78207103, 78207104, 78207106, 78207107, 78207108, 78207111, 78207113, 78207114, 78207115, 78207116, 78207117, 78207118, 78207119, 78207120, 78207121, 78207122, 78207123, 78207124, 78207125, 78207129.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Mike Judy
585-338-6000
Manufacturer Reason
for Recall		 The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
FDA Determined
Cause 2		 Device Design
Action Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.
Quantity in Commerce 69 motors
Distribution Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
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 = HNO and Original Applicant = BAUSCH & LOMB, INC.
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