| 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-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 1742972H 1742973H 1742976H 1742978H 1743078H 1743400H 1744476H 1744481H 1744485H 1744825H 1744938H 1745226H 1745227H 1745228H 1745236H 1745239H 1745240H 1745241H 1745242H 1745795H 1746416H 1746876H 1747429H 1747430H 1747431H 1747432H 1747433H 1747434H 1747435H 1747440H 1747441H 1747450H 1747453H 1747454H 1748102H 1748377H 1748380H 1748381H 1748382H 1748383H 1748385H 1748387H 1748389H 1748390H 1748394H 1748396H 1748397H 1748402H 1748403H 1748404H 1748958H 1748982H 1749454H 1749765H 1749769H 1750191H 1750258H 1750264H 1750493H 1750496H 1750506H 1750508H 1750509H 1750516H 1750517H 1750674H 1750675H 1750677H 1751954H 1752223H 1752819H 1752838H 1752974H 1753131H 1753135H 1753136H 1753143H 1753144H 1754060H 1754092H 1754115H 1754122H 1754127H 1754939H 1755021H 1755151H 1755152H 1755163H 1755416H 1755417H 1755418H 1756025H 1756136H 1756242H 1756243H 1756437H 1757519H 1757592H 1758277H 1758444H 1758612H 1758937H 1759333H 1759825H 1759832H 1760634H 1760635H 1760636H 1760637H 1760638H 1760642H 1760644H 1760645H 1760646H 1760650H 1760655H 1760656H 1760661H 1760667H 1760668H 1760674H 1760675H 1760676H 1760677H 1760678H 1760695H 1760696H 1760697H 1760700H 1761640H 1761661H 1761758H 1762788H 1762814H 1763147H 1763150H 1763920H 1763923H 1763954H 1763963H 1766139H 1766141H 1766150H 1766155H 1766156H 1766466H 1766467H 1766468H 1766469H 1767448H 1768134H 1768164H 1768288H 1768726H 1768770H 1768783H 1768793H 1769110H 1769220H 1769232H 1770783H 1770785H 1770894H 1771343H 1771346H 1771352H 1771367H 1771374H 1773233H 1773427H 1773827H 1774086H 1774087H 1774100H 1774106H 1774107H 1774109H 1774309H 1774795H 1775179H 1775180H 1775193H 1776190H 1776191H 1776200H 1776288H 1776296H 1777288H 1777434H 1777603H 1777609H 1777612H 1777619H 1778214H 1778325H 1778391H 1778396H 1778722H 1778919H 1780487H 1780553H 1781175H 1781176H 1781404H 1781435H 1781540H 1781541H 1781542H 1781545H 1781796H 1781825H 1782428H 1782616H 1782617H 1783490H 1783585H 1783586H 1783780H 1783826H 1783827H 1784153H 1784395H 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 1798993H 1800012H 1800702H 1801156H 1801508H 1801545H 1801849H 1806580H 1807356H 1808951H 1809685H 425727 428313 427054 430459 428509 432689 432023 436046 438164 435993 435493 436028 436390 436618 434019 434605 435486 435152 435198 434885 434239 437227 439231 438926 438936 436469 438662 435957 435870 439257 436978 437899 437178 436507 438400 438273 438440 432587 434130 434583 435382 436483 436353 437599 437981 438507 438640 438716 438932 439145 439389 437556 422984 421235 423376 423924 423618 424353 424447 424469 424183 424720 424693 425001 424713 424685 424965 423821 425192 425094 425135 425647 425686 425386 425537 425601 425732 425923 426264 426170 426267 426062 426479 426424 426633 426550 425353 426976 426599 427644 427321 427325 427414 426871 427723 428274 427978 428257 428236 428656 428956 428794 428280 428466 429193 428483 428555 428521 429167 429346 429218 428847 429660 429396 429766 430087 430148 429799 430079 430140 429617 430302 430421 430659 430685 430478 430884 430660 430838 431667 430933 431978 431757 431714 431601 430160 431836 431913 431926 432177 432201 432274 432281 432567 432797 432509 432579 432676 432685 432857 432683 432954 433572 432853 433354 433102 433853 433838 433842 433894 434037 433654 433974 433769 434416 434424 434412 434242 434755 434537 434866 434858 434464 435667 435239 435394 435410 435669 435657 435947 435687 435862 436136 436248 436073 435817 436689 436240 436564 436784 436568 436566 437045 436834 437225 436097 437591 437420 437417 437725 438272 438589 438127 438539 438380 438232 438124 438282 438238 438608 438854 438881 438865 438960 438302 426196 425889 425891 426126 426123 426121 426031 425979 425850 426566 426242 426604 426590 426680 426739 426822 426767 425657 427073 426806 427246 427466 427492 427665 427756 427653 427950 427837 428095 428088 427980 428102 428000 427703 428130 428011 428343 428203 428026 428589 428421 428506 428574 428094 428188 428286 428597 428457 428591 428817 428769 428850 428614 428761 428858 428993 429034 428967 429313 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435672 435820 436602 436489 436760 436468 436736 436985 436774 437034 437025 436895 437874 436929 437182 437915 437898 437704 437671 437248 437091 438069 437147 437574 437600 437706 437652 437778 438088 438143 437773 438144 437784 438171 438396 438236 438237 438422 438410 438394 438438 438056 438235 438431 438473 438318 438529 438374 438778 439010 438922 438931 422193 423051 422569 422330 422906 423273 423007 423615 423619 423930 423556 423735 424400 424566 424418 425086 425610 424031 425379 425382 425405 425544 425515 423898 425937 426149 425954 425648 425669 426309 424030 427236 427491 426705 427036 427337 426927 428186 427429 427901 428273 428122 428721 426956 428703 428560 428876 429516 429654 428672 428514 428605 428606 429851 428620 427674 |
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 2 | 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 |
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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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