Recall Z-1694-2016
Alcon Research, Ltd. · initiated August 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 1742059H 1742062H 1742068H 1742070H 1742071H 1742072H 1742079H 1742650H 1742654H 1742972H 1742973H 1742976H 1742978H 1743078H 1743400H 1744476H 1744481H 1744485H 1744825H 1744938H 1745226H 1745227H 1745228H 1745236H 1745239H 1745240H 1745241H 1745242H 1745795H 1746416H 1746876H 1747429H 1747430H…
Reason for recall
The product has potential to leak beyond their design specification.
FDA-determined cause: Process control
Action taken
The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
Details
- Recall number
- Z-1694-2016
- Initiated
- August 11, 2015
- Posted by FDA
- May 18, 2016
- Terminated
- April 20, 2017
- Product code
- NGY – Cannula, Trocar, Ophthalmic
- Quantity
- 30,701 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…
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1692-2016 Class II | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |
| Z-1693-2016 Class II | 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of…The product has potential to leak beyond their design specification. | 08/11/2015Terminated |