Class 2 Device Recall Ophthalmic Valved Trocar Cannula (23G and 25G)

• Date Initiated by Firm: August 11, 2015
• Date Posted: May 18, 2016
• Recall Status: Terminated on April 20, 2017
• Recall Number: Z-1694-2016
• Recall Event ID: 73777
• Product Classification: Cannula, trocar, ophthalmic - Product Code NGY
• 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.
• Code Information: 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 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1785053H 1785054H 1785056H 1785061H 1785062H 1785063H 1785064H 1785066H 1785069H 1785070H 1785079H 1785082H 1785083H 1785085H 1785095H 1785097H 1785669H 1785932H 1785977H 1785986H 1786135H 1786453H 1786534H 1786535H 1786759H 1786801H 1786859H 1786861H 1786867H 1786870H 1787112H 1787113H 1787114H 1787311H 1787534H 1787972H 1788071H 1788074H 1788075H 1788077H 1788085H 1788087H 1788091H 1788092H 1788102H 1788103H 1788109H 1788593H 1788758H 1789473H 1789669H 1789670H 1789732H 1789745H 1789750H 1790363H 1790536H 1790999H 1791001H 1791003H 1791906H 1791907H 1791910H 1792248H 1792604H 1792822H 1792823H 1792824H 1792884H 1792885H 1792886H 1792887H 1792895H 1792913H 1793594H 1793602H 1793607H 1793608H 1793609H 1793611H 1794707H 1794818H 1794891H 1794991H 1795393H 1795395H 1795488H 1795500H 1795504H 1795513H 1795516H 1795761H 1796234H 1796235H 1796236H 1796238H 1796241H 1796247H 1796251H 1796256H 1796257H 1796272H 1796338H 1797173H 1797800H 1798183H 1798184H 1798187H 1798200H 1798986H 1798988H 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• Recalling Firm/ Manufacturer: Alcon Research, Ltd.; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Alcon Customer Service; 800-862-5266
• Manufacturer Reason for Recall: The product has potential to leak beyond their design specification.
• FDA Determined Cause: Process control
• Action: The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
• Quantity in Commerce: 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, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.