FDA Device recall Z-1694-2016
Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments with…
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments with… 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-1694-2016 |
| 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
Custom Paks containing 23G and 25G valved trocar cannula provide 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: 1707828H 1710591H 1710852H 1710853H 1713426H 1713909H 1714519H 1714520H 1715966H 1715967H 171596…Lot Numbers: 1707828H 1710591H 1710852H 1710853H 1713426H 1713909H 1714519H 1714520H 1715966H 1715967H 1715968H 1715969H 1715973H 1715974H 1715975H 1715978H 1715985H 1715987H 1715990H 1715991H 1715998H 1715999H 1716000H 1716820H 1716821H 1717967H 1718269H 1718273H 1718369H 1718370H 1719092H 1720758H 1720765H 1721380H 1721388H 1721395H 1721590H 1721896H 1722499H 1723082H 1723088H 1723124H 1723841H 1723845H 1723846H 1723876H 1724755H 1724756H 1726782H 1726930H 1726931H 1727056H 1727768H 1729898H 1729997H 1730138H 1730976H 1731351H 1732658H 1732662H 1733829H 1733830H 1734007H 1734008H 1734911H 1735731H 1735814H 1735911H 1735923H 1735928H 1736349H 1736859H 1736860H 1736862H 1736864H 1736865H 1736867H 1736870H 1736874H 1736877H 1736885H 1737097H 1738696H 1738899H 1738938H 1739014H 1739016H 1739025H 1739336H 1739338H 1739341H 1739346H 1741490H 1741507H 1741519H 1741573H 1741945H 1742057H 1742059 |
|---|
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-1694-2016%22
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