Recall Z-0104-2009 ยท HNO Keratome, Ac-Powered
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.
| Date | Oct 22, 2008 (initiated Apr 23, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040204 | ZYOPTIX XP MICROKERATOME Bausch & Lomb, Inc., Mar 22, 2004 |