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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon 23G NonValved Trocar Cannula and Infusion Cannula

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  Class 2 Device Recall Alcon 23G NonValved Trocar Cannula and Infusion Cannula see related information
Date Initiated by Firm May 29, 2012
Date Posted September 27, 2012
Recall Status1 Terminated 3 on February 12, 2013
Recall Number Z-2470-2012
Recall Event ID 62419
Product Classification Cannula, trocar, ophthalmic - Product Code NGY
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Alcon Research, LTD.
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact Customer Service
800-862-5266
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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: ReplacementCannulas@alconlabs.com. For questions customers should call 1-800-862-5266.
Quantity in Commerce 93,319 (30, 413 distributed domestically & 62,906 internationally)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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