BEUDAMED
    FDA Recall Terminated

    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: Z-0104-2009 · Initiated April 23, 2008

    Recall

    Recall Number
    Z-0104-2009
    Event Number
    47839
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HNO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 23, 2008
    Posted
    October 22, 2008
    Terminated
    April 2, 2012
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    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.

    Reason

    The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.

    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.

    Distribution

    Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.

    Quantity

    44 trays