BEUDAMED
    FDA Recall Terminated

    WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.

    Recall: Z-2292-2011 · Initiated April 18, 2011

    Recall

    Recall Number
    Z-2292-2011
    Event Number
    58601
    Firm
    Wavelight AG Industriegebiet Doellnitz 5 Pressath Germany
    FEI Number
    3003288808
    Product Code
    HNO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2011
    Posted
    May 25, 2011
    Terminated
    September 23, 2011

    Description

    WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.

    Reason

    The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.

    Action

    WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers to discontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3. Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.

    Distribution

    Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.

    Quantity

    55 units