BEUDAMED
    FDA Recall Terminated

    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.

    Recall: Z-2470-2012 · Initiated May 29, 2012

    Recall

    Recall Number
    Z-2470-2012
    Event Number
    62419
    Firm
    Alcon Research, LTD. 9965 Buffalo Speedway
    FEI Number
    1000117501
    Product Code
    NGY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 29, 2012
    Posted
    September 27, 2012
    Terminated
    February 12, 2013
    Address
    Houston, TX, 77054-1309

    Description

    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.

    Reason

    This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.

    Action

    Alcon sent an Urgent a Voluntary Medical Device Correction letter on May 9, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed NOT to use the affected product, instead customers should use a 1-Count Valved Trocar Cannula and to complete and immediately return the Medical Device Correction Response Form to Alcon via fax at: (817) 916-9087 or email to: [email protected]. For questions customers should call 1-800-862-5266.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

    Quantity

    93,319 (30, 413 distributed domestically & 62,906 internationally)