Recall Z-0104-2009

Bausch & Lomb Inc · initiated April 23, 2008

Terminated

Product

Zyoptix 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.

Codes / lots: 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

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: Device Design

Action taken

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.

Details

Recall number
Z-0104-2009
Initiated
April 23, 2008
Posted by FDA
October 22, 2008
Terminated
April 2, 2012
Product code
HNO – Keratome, Ac-Powered
Quantity
44 trays
Distribution
Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
Recalling firm
Bausch & Lomb Inc, Rochester, NY

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0103-2009 Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is…The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. 04/23/2008Terminated