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U.S. Department of Health and Human Services

Class 2 Device Recall Ophthalmic Valved Trocar Cannula (23G and 25G)

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  Class 2 Device Recall Ophthalmic Valved Trocar Cannula (23G and 25G) see related information
Date Initiated by Firm August 11, 2015
Date Posted May 18, 2016
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-1692-2016
Recall Event ID 73777
Product Classification Cannula, trocar, ophthalmic - Product Code NGY
Product Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
Code Information Lot Numbers: 15011624X, 15013312X, 15013313X, 15014272X, 15014273X, 15015769X, 15016782X, 15016783X, 15016784X, 15018549X, 15018550X, 15018554X, 15018602X, 15018603X, 15018606X, 15018888X, 15018890X, 15020828X, 15020830X, 15021333X, 15021337X, 15022350X, 15022414X, 15022416X, 15025385X, 15025395X, 15027298X, 15027819X, 15027820X, 15027834X, 15027843X, 15028267X, 15028268X, 15031226X, 15031229X, 15031231X, 15031232X, 15032112X, 15034244X, 15034779X
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Alcon Customer Service
800-862-5266
Manufacturer Reason
for Recall		 The product has potential to leak beyond their design specification.
FDA Determined
Cause 2		 Process control
Action The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
Quantity in Commerce 83,448 units
Distribution United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay
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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