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U.S. Department of Health and Human Services

Class 2 Device Recall Zyoptix XP Microkeratome tray

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 Class 2 Device Recall Zyoptix XP Microkeratome traysee related information
Date Initiated by FirmApril 23, 2008
Date PostedOctober 22, 2008
Recall Status1 Terminated 3 on April 02, 2012
Recall NumberZ-0104-2009
Recall Event ID 47839
510(K)NumberK040204 
Product Classification Ac-Powered Keratome - Product Code HNO
ProductZyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
Code Information Tray/motor serial numbers: 11061/77318906, 10980/77318909, 11019/77318920, 11029/77318925, 11084/77318926, 10969/77504001, 11046/77504002, 11000/77504005, 11088/77504006, 11045/77504007, 11068/77504008, 11108/77504009, 10972/77504011, 11106/77504014, 11021/77504015, 11177/77732302, 11202/77732307, 11091/77732316, 11031/77732318, 11066/77898701, 11026/77898702, 11077/77898704, 11120/77898705, 11103/77898706, 11040/77898707, 11192/77898708, 11190/77898712, 11174/77898713, 11153/77898714, 11030/77898715, 11111/78080317, 11047/78080319, 11150/78080321, 10904/78080323, 11149/78080324, 11096/78080325, 11041/78080333, 11081/78080334, 11064/78080335, 11221/78080339, 11122/78080340, 11034/78080341, 11140/78080342, 11089/78207127
FEI Number 1317628
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information ContactMike 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
ActionPhone 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 Commerce44 trays
DistributionWorldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
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 = HNO
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