BEUDAMED
    FDA Recall Terminated

    Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)

    Recall: Z-0348-2007 · Initiated September 15, 2006

    Recall

    Recall Number
    Z-0348-2007
    Event Number
    36711
    Firm
    Advanced Medical Optics, Inc.
    FEI Number
    3003843509
    Product Code
    LPN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2006
    Posted
    March 1, 2007
    Terminated
    February 17, 2010
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933

    Description

    Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)

    Reason

    Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

    Action

    Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

    Distribution

    Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

    Quantity

    182,678 units for all US products, 2,943,207 units worldwide