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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73777

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 11, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alcon Research, Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

Z-1692-2016
Recall number
Z-1692-2016
Initiated
August 11, 2015
Classification
Class II
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
83,448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product has potential to leak beyond their design specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product has potential to leak beyond their design specification.

Code information

Lot Numbers: 15011624X, 15013312X, 15013313X, 15014272X, 15014273X, 15015769X, 15016782X, 15016783X, 15016784X, 15018549X, 15018550X, 15018554X, 15018602X, 15018603X, 15018606X, 15018888X, 15018890X, 15020828X, 15020830X, 15021333X, 15021337X, 15022350X, 15022414X, 15022416X, 15025385X, 15025395X, 15027298X, 15027819X, 15027820X, 15027834X, 15027843X, 15028267X, 15028268X, 15031226X, 15031229X, 15031231X, 15031232X, 15032112X, 15034244X, 15034779X

Distribution pattern

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

device · product 2 of 3

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.

Z-1693-2016
Recall number
Z-1693-2016
Initiated
August 11, 2015
Classification
Class II
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
225,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product has potential to leak beyond their design specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product has potential to leak beyond their design specification.

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

Distribution pattern

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

device · product 3 of 3

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.

Z-1694-2016
Recall number
Z-1694-2016
Initiated
August 11, 2015
Classification
Class II
Status
Terminated
Recalling firm
Alcon Research, Ltd.
Quantity
30,701 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product has potential to leak beyond their design specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product has potential to leak beyond their design specification.

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 429314 429195 429330 429317 429232 429355 429181 429360 429727 429646 429508 429805 429715 429784 429933 429917 432606 429983 429824 430129 430106 430493 430416 430159 430567 430505 430568 430614 430571 430671 430658 430686 430758 430775 430767 430899 430785 431296 430929 430921 431022 431033 431178 431306 430956 431103 430911 431423 431564 431377 431361 431456 431572 431571 431552 431614 431736 431761 431805 432278 432083 432320 432216 432370 432331 431711 432399 432527 432339 432444 432611 432791 432575 432505 432792 432802 432749 432793 432632 432687 432801 432690 432884 432803 432767 433022 433008 432990 433217 433065 432944 433162 432956 433211 433122 433137 433344 433265 432379 433614 433524 433300 435526 434745 433553 433540 433679 433862 433860 434069 433937 433787 434058 434396 434146 434248 434140 434857 434147 434252 434597 434410 434423 435005 434422 434498 434700 434873 434059 435561 435734 435717 435677 435720 433795 435689 435987 435760 435671 435594 435914 435999 435621 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

Distribution pattern

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