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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 62419
Product Type Devices
Status Ongoing
Recalling Firm Alcon Research, LTD.
City Houston
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-29
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation. Class II 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. 30, 413 distributed domestically & 62,906 internationally Z-2470-2012