Recall Z-2470-2012— Alcon Research, LTD.

Class II FDA medical device recall by Alcon Research, LTD., initiated 2012-05-29, terminated 2013-02-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm

Alcon Research, LTD.

Classification

Class II

Status

Terminated

Initiated

2012-05-29

Terminated

2013-02-12

Firm location

Houston, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.