| Class 2 Device Recall Ophthalmic Valved Trocar Cannula (23G and 25G) | |
Date Initiated by Firm | August 11, 2015 |
Date Posted | May 18, 2016 |
Recall Status1 |
Terminated 3 on April 20, 2017 |
Recall Number | Z-1693-2016 |
Recall Event ID |
73777 |
Product Classification |
Cannula, trocar, ophthalmic - Product Code NGY
|
Product | 23G and 25G Constellation Totalplus Paks provides 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: 1711482H 1711485H 1714709H 1714711H 1714712H 1714713H 1714715H 1714716H 1714717H 1714736H 1714737H 1714738H 1714739H 1717871H 1717872H 1717874H 1717895H 1717896H 1717902H 1726095H 1726102H 1726103H 1726104H 1726105H 1726106H 1726107H 1726118H 1726119H 1726120H 1726121H 1726122H 1731592H 1731595H 1731929H 1731930H 1731931H 1731932H 1731933H 1734476H 1734478H 1734479H 1734480H 1734481H 1734546H 1734547H 1734548H 1734549H 1734550H 1734551H 1734552H 1734559H 1734560H 1734561H 1734562H 1734563H 1734564H 1734565H 1734566H 1734567H 1734568H 1734569H 1734570H 1734571H 1734572H 1734573H 1734574H 1735125H 1735126H 1735127H 1735128H 1735129H 1735130H 1735131H 1735132H 1746173H 1746197H 1746198H 1746199H 1746200H 1746201H 1747011H 1747012H 1747013H 1747014H 1747015H 1749215H 1749216H 1749217H 1749218H 1749219H 1749220H 1749221H 1751293H 1753301H 1753302H 1753303H 1753323H 1753324H 1753325H 1753326H 1753327H 1753328H 1753329H 1753339H 1753342H 1753346H 1753347H 1753348H 1753360H 1753361H 1753362H 1753363H 1756285H 1756286H 1759094H 1759095H 1759096H 1759097H 1759098H 1759099H 1759100H 1759101H 1759171H 1759172H 1759173H 1759174H 1759175H 1759176H 1759182H 1759183H 1759185H 1759186H 1759195H 1759196H 1759197H 1759198H 1764487H 1764488H 1764489H 1764710H 1764711H 1764712H 1764713H 1764714H 1764715H 1764716H 1764717H 1764718H 1764719H 1764720H 1764721H 1764722H 1764723H 1764735H 1764736H 1767599H 1773000H 1773001H 1773015H 1773016H 1773017H 1773018H 1775519H 1775520H 1775521H 1775522H 1775523H 1775524H 1775525H 1775526H 1780757H 1780758H 1780759H 1780760H 1780761H 1780762H 1780763H 1783252H 1783259H 1783260H 1783261H 1783272H 1783273H 1783274H 1783275H 1783276H 1783293H 1783294H 1783295H 1783296H 1783298H 1783299H 1783300H 1785543H 1791450H 1791452H 1791478H 1791481H 1791484H 1791485H 1791486H 1794207H 1794208H 1794209H 1794210H 1794221H 1794222H 1794223H 1794224H 1794225H 1794226H 1794229H 1702839H 1702840H 1702841H 1708745H 1708746H 1708747H 1708749H 1708750H 1708751H 1708752H 1708753H 1708763H 1708764H 1708765H 1708766H 1708767H 1711476H 1711486H 1711487H 1711488H 1714718H 1714719H 1714720H 1714721H 1714741H 1714745H 1714746H 1714747H 1717882H 1717883H 1717884H 1717885H 1717886H 1717887H 1717888H 1717897H 1717898H 1717899H 1717900H 1717901H 1723375H 1723376H 1725849H 1725850H 1725851H 1725862H 1725868H 1726096H 1726097H 1726098H 1726099H 1726108H 1726109H 1726110H 1726111H 1726112H 1726113H 1726114H 1726115H 1726116H 1731593H 1731594H 1731596H 1734482H 1734483H 1734484H 1734485H 1734486H 1734487H 1734488H 1734489H 1734490H 1734491H 1734492H 1734493H 1734494H 1734495H 1734512H 1734513H 1734514H 1734515H 1734516H 1734576H 1734581H 1734582H 1734583H 1734584H 1734585H 1734586H 1734587H 1734588H 1734589H 1734590H 1734591H 1734592H 1734593H 1734594H 1746174H 1746175H 1746176H 1746177H 1746178H 1746179H 1746191H 1746192H 1746193H 1746202H 1746203H 1746204H 1746221H 1746222H 1749093H 1749094H 1749095H 1749096H 1749097H 1749098H 1749099H 1749100H 1749101H 1749102H 1749103H 1751294H 1753296H 1753297H 1753298H 1753299H 1753313H 1753314H 1753315H 1753316H 1753317H 1753318H 1753319H 1753320H 1753321H 1753330H 1753331H 1753332H 1753340H 1753341H 1753343H 1753344H 1753345H 1753349H 1753350H 1753351H 1753364H 1753365H 1753366H 1753367H 1753368H 1756287H 1759187H 1759188H 1759199H 1759200H 1759201H 1759216H 1759217H 1759218H 1759219H 1759220H 1759221H 1759222H 1759223H 1759224H 1759225H 1759226H 1759227H 1759228H 1759229H 1759230H 1759231H 1759232H 1759233H 1759234H 1759235H 1759236H 1759237H 1759238H 1759239H 1759240H 1759241H 1759242H 1759243H 1759244H 1759245H 1759246H 1759247H 1759248H 1759249H 1759250H 1759251H 1759252H 1759253H 1759254H 1759256H 1764670H 1764676H 1764677H 1764680H 1764681H 1764683H 1764684H 1764686H 1764687H 1764688H 1764697H 1764701H 1764703H 1764704H 1764705H 1764730H 1764731H 1764732H 1764733H 1764737H 1764738H 1764739H 1764740H 1775354H 1775355H 1775356H 1775357H 1775358H 1775359H 1776624H 1776625H 1776626H 1776627H 1776628H 1776632H 1776633H 1776634H 1776635H 1776636H 1780702H 1780703H 1780716H 1780717H 1780718H 1780719H 1780720H 1780721H 1780722H 1780723H 1780724H 1780725H 1780726H 1780727H 1780728H 1780729H 1780730H 1780731H 1780732H 1783253H 1783254H 1783255H 1783256H 1783257H 1783258H 1783262H 1783263H 1783264H 1783265H 1783277H 1783278H 1783297H 1783301H 1783302H 1785544H 1785545H 1785546H 1791451H 1791453H 1791460H 1791461H 1791462H 1791465H 1791473H 1791475H 1791476H 1791477H |
Recalling Firm/ Manufacturer |
Alcon Research, Ltd. 6201 South Fwy Fort Worth TX 76134-2099
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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 2 | Process control |
Action | The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage. |
Quantity in Commerce | 225,000 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 |
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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.
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