Alcon Research, LTD. 9965 Buffalo Speedway Recalls
Showing 1-3 of 3 recalls
Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.
Alcon Custom Pak
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.
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 ophth
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.
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.