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.
FDA Recall Z-0104-2009 · Posted 2008-10-22
Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHNO
Date Initiated2008-04-23
Date Terminated2012-04-02
Product Quantity44 trays
Reason for Recall
The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.