BEUDAMED
    FDA Recall Terminated

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    Recall: Z-1597-2016 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-1597-2016
    Event Number
    73767
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    October 6, 2014
    Posted
    May 3, 2016
    Terminated
    March 31, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    Reason

    The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.

    Action

    The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.

    Distribution

    Nationwide Distribution.

    Quantity

    6597 packs