FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
- Recall number
- Z-0103-2009
- Recalling firm
- Bausch & Lomb Inc
- Product
- Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. 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
- 69 motors
- Distribution
- Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
- Lot, serial or model codes
- 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.
- 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