FDAClass IIMay 25, 2016

Alcon 23G and 25G Valved Entry System provides access recall

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…

Why was Alcon 23G and 25G Valved Entry System provides access recalled?

The product has potential to leak beyond their design specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Alcon Research, Ltd.
Quantity
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
Recall date
May 25, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls