FDA Device recall Z-1692-2016
Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23…
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II 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 23… by Alcon Research, citing the product has potential to leak beyond their design specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1692-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-11 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alcon Research |
| Distribution | PR |
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.
Reason
The product has potential to leak beyond their design specification.
Identifiers
| code_info | Lot Numbers: 15011624X, 15013312X, 15013313X, 15014272X, 15014273X, 15015769X, 15016782X, 15016783X, 15016784X,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1692-2016%22
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