BEUDAMED
    FDA Recall Terminated

    SKBM Microkeratome cutting tool

    Recall: Z-0612-03 · Initiated November 18, 2002

    Recall

    Recall Number
    Z-0612-03
    Event Number
    25047
    Firm
    Alcon Laboratories, Inc
    FEI Number
    1610287
    Product Code
    HNO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2002
    Posted
    March 6, 2003
    Terminated
    July 8, 2003
    Address
    6201 South Freeway PO Box 6600, Fort Worth, TX, 76134-2099

    Description

    SKBM Microkeratome cutting tool

    Reason

    Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.

    Action

    Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.

    Distribution

    Distribution was nationwide and to the following foreign countries: Spain, Taiwan, UK, Mexico, Brazil, India, France, Ireland, China, Lebanon, Germany, Australia, Italy, Saudi Arabia, Greece, Japan, Netherland, Turkey, Korea, Romania, Latvia, Belgium, Switzerland, Malaysia, Thailand, Portugal, Phillipines, Canada, Sweden, Hungary, Argentina, Poland, Norway, Peru, Russia, Venezuela, Vietnam, Ecuador, Ukraine, Cyprus, Singapore, Chile, Nepal, Honduras, Colombia, and the Czech Republic.

    Quantity

    567