Z-0104-2009

Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the...

Name: Z-0104-2009 Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the...
Creator: Bausch & Lomb Inc
Published: 2008-04-23
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2008-04-23 / Terminated / root cause: design

FDA source

Bausch & Lomb Inc began a recall of 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... on 2008-04-23. The reason FDA records is "The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0104-2009
Status: Terminated
Initiated: 2008-04-23
Posted: 2008-10-22
Terminated: 2012-04-02
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HNO Keratome, Ac-Powered
Reason for recall: The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Root cause tag: design
FDA root cause: 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: 44 trays
Distribution: Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
Product codes and 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

Product code HNO

K040204Class IZyoptix Xp MicrokeratomeBausch & Lomb, Inc. / cleared 2004-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)