BEUDAMED
    FDA Recall Terminated

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    Recall: Z-3050-2017 · Initiated June 30, 2017

    Recall

    Recall Number
    Z-3050-2017
    Event Number
    77823
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    NCF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2017
    Terminated
    August 27, 2019
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    Reason

    Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.

    Action

    The Market Action was initiated with Initial telephone contact to all affected customers starting June 30, 2017. These customers were informed of the issue, and advised not to use their ORA Carts for calculations with the lens model affected on their specific system. A confirmatory letter (Attachment 4) was also sent via overnight mail to these customers July 12, 2017. As of July 12, 2017, Alcon has identified 8 ORA Carts that are affected by the software coding error. Alcon has reset the IOL databases on all 8 of the identified affected ORA Carts.

    Distribution

    Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom

    Quantity

    367 units