FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: 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.
- Recall number
- Z-0104-2009
- Recalling firm
- Bausch & Lomb Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-04-23
- Posted
- 2008-10-22
- Terminated
- 2012-04-02
- Reason
- The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
- 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
- 44 trays
- Distribution
- Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K040204"]
- PMA numbers
- not on file
- Product code
- HNO
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28