BEUDAMED
    FDA Recall Terminated

    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

    Recall: Z-1445-2014 · Initiated March 14, 2014

    Recall

    Recall Number
    Z-1445-2014
    Event Number
    67755
    Firm
    Alcon LenSx, Inc. 33 Journey Aliso
    FEI Number
    3008772169
    Product Code
    OOE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 14, 2014
    Posted
    April 9, 2014
    Terminated
    October 16, 2014
    Address
    Viejo, CA, 92656-5346

    Description

    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

    Reason

    Alcon LenSx received reports of unexpected downward motion of the gantry.

    Action

    Alcon LenSx Inc advised customers of a Medical Device Correction being initiated for specific serial numbers of the LenSx Laser System for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Alcon sent customer notification letters via mail during the week of March 17, 2014. The letter titled "Medical Device Correction", advised customers of the correction and provided: the product's description with serial number(s), description of the potential condition, advise on action to be taken by the user, transmission of the notice, and a contact reference person. The letter also contained a section for customers to sign and return the page of the Notice to Alcon.

    Distribution

    Worldwide Distribution.

    Quantity

    75