BEUDAMED
    FDA Recall Terminated

    Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF

    Recall: Z-0539-04 · Initiated February 9, 2004

    Recall

    Recall Number
    Z-0539-04
    Event Number
    28264
    Firm
    Staar Surgical Co Inc
    FEI Number
    2023826
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2004
    Posted
    February 18, 2004
    Terminated
    January 4, 2005
    Address
    1911 Walker Ave, Monrovia, CA, 91016-4846

    Description

    Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF

    Reason

    Risk of hyperopic refractive changes.

    Action

    Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.

    Distribution

    Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.

    Quantity

    No quantity applies.