Z-1692-2016Class II

Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical...

Name: Z-1692-2016 Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical...
Creator: Alcon Research, Ltd.
Published: 2015-08-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2015-08-11 / Terminated / root cause: manufacturing process

FDA source

Alcon Research, Ltd. began a recall of 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... on 2015-08-11. FDA classified it as Class II and gives the reason as "The product has potential to leak beyond their design specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-11
Posted: 2016-05-18
Terminated: 2017-04-20
Recalling firm: Alcon Laboratories
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.
Product code: NGY Cannula, Trocar, Ophthalmic
Reason for recall: The product has potential to leak beyond their design specification.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1692-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-18
Z-1693-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-18
Z-1694-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-18

Product code NGY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)