Class 2 Device Recall Alcon CustomPak Surgical Procedure Packs

• Date Initiated by Firm: August 24, 2020
• Create Date: October 09, 2020
• Recall Status: Terminated on November 17, 2021
• Recall Number: Z-0095-2021
• Recall Event ID: 86315
• 510(K)Number: k880961
• Product Classification: General surgery tray - Product Code LRO
• Product: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
• Code Information: Pak Number followed by the corresponding lot numbers are as follows: 0433-72 2359088H 0433-72 2362546H 10008-15 2364745H 10391-04 2383902H 10391-04 2388582H 10391-04 2397523H 10477-17 2346459H 10477-18 2383904H 1087-63 2353407H 1087-64 2395495H 11016-11 2350017H 11311-07 2403959H 11311-07 2406031H 11345-08 2363773H 11345-08 2363774H 11345-08 2363775H 11437-03 2362137H 11437-03 2379506H 11437-03 2385658H 11437-03 2394132H 11458-17 2370067H 11458-17 2375171H 11458-17 2390120H 11458-17 2393525H 11458-17 2400520H 11786-01 2347153H 11786-01 2380332H 1179-43 2379382H 1179-43 2384124H 1179-43 2384125H 1179-43 2388444H 1179-43 2388445H 11876-18 2362142H 11876-18 2369176H 11876-18 2379510H 1231-57 2365132H 1231-57 2369489H 1231-57 2372302H 1231-57 2383379H 1231-57 2391174H 1231-57 2393089H 1231-57 2399904H 1231-57 2401798H 1231-57 2403559H 12732-05 2394138H 12736-09 2365968H 12736-09 2375271H 12736-09 2390575H 12736-09 2392097H 12736-09 2395160H 12878-13 2384211H 12878-13 2385672H 12896-09 2358037H 12896-09 2376070H 12896-09 2385542H 12896-09 2387051H 12896-09 2394141H 12896-09 2395582H 13152-08 2384214H 13193-11 2372672H 13193-11 2394902H 13194-12 2346890H 13194-13 2363370H 13194-13 2369833H 13194-13 2377937H 13194-13 2390027H 13194-13 2391920H 13194-13 2392322H 13194-13 2396531H 13194-13 2400270H 13194-13 2402421H 13235-16 2324761H 13391-09 2315328H 13391-09 2343461H 13391-09 2350133H 13391-09 2357090H 13391-10 2370048H 13391-10 2378299H 13391-10 2380086H 13391-10 2390108H 13391-10 2393512H 13391-10 2396778H 13391-10 2399535H 13477-10 2357278H 13477-10 2361677H 13477-10 2363897H 13477-10 2365971H 13477-10 2370199H 13477-10 2375273H 13477-10 2380877H 13477-10 2390175H 13477-10 2392100H 13477-10 2394534H 13667-08 2346266H 13667-09 2361271H 13667-09 2365630H 13667-09 2378038H 13667-09 2383643H 13667-09 2396582H 13667-09 2400368H 13698-13 2384221H 13698-13 2387057H 13698-13 2394149H 13699-16 2362174H 13699-16 2389133H 13699-16 2392378H 13699-16 2399300H 13700-16 2366535H 13700-16 2388008H 13700-16 2396979H 13702-18 2362175H 13702-18 2379482H 13702-18 2389134H 13702-18 2392379H 13702-18 2395588H 13777-12 2369193H 13777-12 2389136H 13777-12 2392382H 13777-12 2396981H 13909-02 2362177H 13909-02 2385684H 14049-09 2358048H 14049-09 2369194H 14049-09 2379487H 14049-09 2387060H 14049-09 2389139H 14049-09 2392385H 14049-09 2395593H 14049-09 2399305H 14228-06 2376082H 14295-01 2322279H 14295-02 2400274H 14319-06 2373436H 14319-06 2385550H 14319-06 2389142H 14319-06 2392390H 14319-06 2395598H 14329-04 2385268H 14329-04 2401377H 14424-10 2356092H 14424-10 2357456H 14424-11 2361756H 14424-11 2363987H 14424-11 2370331H 14424-11 2373012H 14424-11 2380958H 14424-11 2390236H 14424-11 2392161H 14424-11 2395249H 14424-11 2400750H 14443-09 2365548H 14443-09 2377947H 14443-09 2383076H 14443-09 2393359H 14443-09 2396539H 14443-09 2400277H 14443-09 2402002H 14489-07 2389143H 14489-07 2392392H 14489-07 2396983H 14569-06 2349153H 14569-06 2372002H 14677-06 2359127H 14677-06 2363381H 14677-06 2377953H 14677-06 2379923H 14677-06 2387761H 14677-06 2387850H 14677-06 2388182H 14692-08 2358055H 14692-08 2358305H 14692-08 2369208H 14692-08 2376088H 14713-04 2353346H 14713-04 2355860H 14713-04 2365788H 14713-04 2367878H 14713-04 2373226H 14713-04 2374926H 14713-04 2392883H 14713-04 2396684H 14713-04 2398537H 14716-01 2350064H 14743-03 2343547H 14743-03 2357287H 14743-03 2365978H 14743-03 2367995H 14743-03 2370207H 14743-03 2378387H 14743-03 2383217H 14743-03 2390180H 14743-03 2392104H 14743-03 2398731H 14743-03 2400645H 14743-03 2402263H 14764-06 2319637H 14764-06 2371523H 14856-06 2373437H 14856-06 2379460H 14856-06 2385698H 14936-03 2376092H 15134-06 2348533H 15134-06 2392318H 15134-06 2392319H 15246-02 2380571H 15286-07 2319652H 15286-08 2367115H 15482-17 2383274H 15482-17 2387319H 15482-17 2392341H 15503-05 2369219H 15503-05 2376097H 15503-05 2376098H 15503-05 2385561H 15503-05 2395606H 15503-05 2396989H 15511-02 2366558H 15641-05 2362192H 15641-05 2369230H 15641-05 2379471H 15641-05 2385705H 15764-03 2379473H 15784-04 2384237H 15784-04 2399319H 15854-02 2384239H 15854-02 2385714H 16003-09 2399521H 16003-09 2399522H 16019-07 2395706H 16088-02 2317774H 16088-02 2319671H 16088-02 2349206H 16108-01 2389157H 16172-07 2346663H 16172-07 2348606H 16172-07 2399575H 16200-11 2358965H 16200-11 2365309H 16243-08 2342892H 16243-10 2365170H 16243-10 2369524H 16243-10 2387753H 16243-10 2387835H 16243-10 2388113H 16243-10 2397925H 16245-02 2374009H 16245-02 2395487H 16245-02 2399399H 16281-01 2376112H 16281-01 2388033H 1635-64 2357924H 1635-64 2366482H 1635-64 2376006H 1635-64 2385616H 1635-64 2389089H 1635-64 2392286H 1635-64 2396942H 16387-01 2362199H 16387-01 2387072H 16387-01 2401282H 16499-02 2376116H 16499-02 2379427H 1667-77 2389090H 1667-77 2392287H 16809-05 2373466H 16895-03 2384260H 16895-03 2385740H 16936-06 2357518H 16936-06 2390255H 16936-06 2392175H 16936-06 2394577H 16936-06 2396900H 16936-06 2400787H 16937-04 2359598H 16937-04 2370369H 16937-04 2390256H 16937-04 2394097H 16937-04 2396901H 16937-04 2398846H 16983-03 2319720H 17026-02 2358974H 17026-03 2367655H 17032-03 2385743H 17064-05 2363924H 17064-05 2370233H 17064-05 2372968H 17064-05 2390583H 17064-05 2393625H 17119-02 2373471H 17119-02 2385595H 17119-02 2395634H 17120-02 2387082H 17251-02 2340478H 17251-02 2340479H 17251-02 2342763H 17251-02 2350210H 17251-02 2370236H 17251-02 2372972H 17251-02 2375307H 17251-02 2378401H 17251-02 2380896H 17251-02 2391615H 17251-02 2392115H 17251-02 2394544H 17251-02 2396842H 17251-02 2398750H 17251-02 2398751H 17251-02 2402274H 17251-02 2403091H 17251-02 2403092H 17272-02 2373475H 17272-02 2385602H 17273-04 2354509H 17273-04 2373476H 17273-04 2384266H 17273-04 2387083H 17273-04 2389179H 17273-04 2392433H 17294-07 2348727H 17294-07 2348728H 17294-07 2361796H 17294-07 2364025H 17294-07 2370383H 17294-07 2375431H 17294-07 2383296H 17294-07 2390269H 17294-07 2392190H 17294-07 2395274H 17294-07 2398853H 17294-07 2400798H 17294-07 2401425H 17346-06 2358885H 17346-06 2360847H 17346-07 2365202H 17346-07 2372369H 17346-07 2374389H 17346-07 2378596H 17346-07 2391209H 17346-07 2393127H 17346-07 2396395H 17346-07 2397952H 17346-07 2399955H 17346-07 2403602H 17423-08 2374391H 17423-08 2383425H 17423-08 2393129H 17423-08 2399959H 17434-03 2380106H 17434-03 2390133H 17434-03 2392447H 17434-03 2392969H 17464-02 2357330H 17464-02 2359548H 17464-02 2366006H 17464-02 2368000H 17464-02 2370239H 17464-02 2375310H 17464-02 2380157H 17464-02 2390196H 17464-02 2392116H 17464-02 2394546H 17464-02 2396844H 17464-02 2398753H 17464-02 2400674H 17474-03 2385752H 17474-03 2392435H 17550-07 2347187H 17550-07 2369553H 17550-07 2372374H 17550-07 2374395H 17550-07 2382029H 17550-07 2389916H 17550-07 2392797H 17550-07 2394706H 17550-07 2396400H 17550-07 2399962H 1765-62 2358235H 1765-62 2368366H 1765-63 2399511H 17766-02 2391138H 17766-02 2397872H 17766-02 2399866H 17770-02 2394179H 17785-04 2366009H 17785-04 2378404H 17785-04 2380902H 17785-04 2390586H 17785-04 2395186H 17785-04 2402275H 17824-03 2395643H 17887-02 2355291H 17887-03 2394394H 17887-03 2396457H 17887-03 2398086H 17955-03 2355126H 17955-04 2378613H 17955-04 2382034H 17955-04 2396404H 17983-03 2394180H 17983-03 2395644H 18021-02 2359682H 18021-02 2368234H 18021-02 2371219H 18021-02 2373764H 18021-02 2381456H 18021-02 2382189H 18021-02 2384707H 18021-02 2399549H 18021-02 2401485H 18086-02 2373060H 18086-02 2383315H 18086-02 2390288H 18086-02 2393739H 18086-02 2394590H 18125-01 2376032H 18125-01 2399277H 18126-01 2358364H 18126-01 2385749H 18126-01 2388051H 18266-03 2367979H 18266-03 2378352H 18266-03 2380841H 18266-03 2388255H 18266-03 2400578H 18419-04 2363084H 18419-05 2367614H 18419-05 2369572H 18419-05 2372399H 18419-06 2378618H 18419-06 2388076H 18419-06 2388124H 18486-01 2359626H 18486-01 2370436H 18486-01 2381022H 18486-01 2388333H 18486-01 2390303H 18486-01 2392214H 18486-01 2395307H 18486-01 2396921H 18486-01 2401090H 18486-01 2401091H 18486-01 2401092H 18512-01 2367047H 18512-01 2370001H 18512-01 2382149H 18512-01 2383109H 18512-01 2388216H 18512-01 2389389H 18512-01 2391424H 18512-01 2393467H 18512-01 2395030H 18521-01 2375472H 18521-01 2395309H 18536-01 2380854H 18536-01 2386119H 18536-02 2393574H 18536-02 2401436H 18536-03 2396805H 18536-03 2398693H 18536-03 2400587H 18536-03 2400588H 18588-01 2391522H 18588-01 2392929H 18588-01 2396743H 18588-01 2398593H 18609-01 2394369H 18609-01 2397986H 1871-69 2387971H 1933-62 2320192H 1933-62 2343517H 1933-62 2363856H 1933-62 2370139H 1933-62 2375234H 1933-62 2380131H 1933-62 2388265H 1933-62 2388402H 1933-62 2402467H 2035-69 2349421H 2035-69 2364050H 2035-70 2368067H 2074-53 2376012H 2074-53 2385621H 2147-63 2315477H 2147-63 2363604H 2147-63 2365699H 2147-63 2378109H 2147-63 2390525H 2147-63 2392005H 2147-63 2395032H 2147-63 2395033H 2147-63 2403922H 2427-54 2379529H 2428-56 2349795H 2428-56 2363608H 2428-56 2378115H 2428-56 2380707H 2428-56 2383708H 2428-56 2393473H 2428-56 2398449H 2428-56 2400452H 2556-71 2350345H 2683-80 2357933H 2683-80 2385627H 2683-80 2392313H 2683-81 2394118H 2683-81 2399265H 2828-67 2376019H 4976-20 2370464H 4976-20 2373074H 4976-20 2375489H 4976-20 2378512H 4976-20 2391711H 4976-21 2395324H 5742-66 2379534H 5742-66 2395553H 5813-53 2366493H 5813-53 2384180H 5813-53 2385632H 6005-11 2373082H 6005-11 2375498H 6005-11 2378520H 6005-11 2396933H 6005-11 2398910H 6241-27 2319818H 6241-27 2320633H 6241-27 2343572H 6241-28 2357375H 6241-28 2363951H 6241-28 2366030H 6241-28 2370281H 6241-28 2378420H 6241-28 2380180H 6241-28 2383253H 6241-28 2395212H 6241-28 2398788H 6241-28 2400716H 6241-28 2401452H 6241-29 2402289H 6374-22 2365265H 6374-22 2369604H 6374-22 2372430H 6374-22 2382065H 6374-22 2388510H 6374-22 2388511H 6374-22 2391235H 6374-22 2392803H 6374-22 2398010H 6374-22 2398011H 6374-22 2400015H 6374-22 2400972H 6374-22 2400973H 6919-65 2354780H 6919-65 2354781H 6919-65 2354782H 6919-65 2354783H 6919-65 2361209H 6919-65 2361210H 6919-65 2361211H 6919-65 2363471H 6919-65 2363472H 6919-65 2377987H 6919-65 2379937H 6919-65 2379938H 6919-65 2379939H 6919-65 2383103H 6919-65 2383104H 6919-65 2393379H 6919-65 2393380H 6919-65 2394931H 6919-65 2394932H 6919-65 2398344H 6919-65 2398345H 6919-65 2400311H 6919-65 2400312H 6919-65 2400313H 6919-65 2402428H 6932-61 2343122H 6932-61 2349004H 6932-61 2359170H 6932-61 2363473H 6932-61 2390479H 6932-61 2393381H 6932-61 2396560H 6932-61 2398346H 6932-61 2400314H 8206-55 2385638H 8306-63 2379538H 8306-63 2385514H 8306-63 2387040H 8306-63 2389100H 8306-63 2392307H 8306-63 2395559H 8306-63 2399276H 8323-20 2363953H 8323-20 2363954H 8323-20 2366033H 8323-20 2366034H 8323-20 2375347H 8323-20 2375348H 8323-20 2388465H 8323-20 2388466H 8323-20 2388467H 8323-20 2393661H 8323-20 2396868H 8323-20 2396869H 8323-20 2398790H 8323-20 2400720H 8323-20 2400721H 8371-60 2362116H 8371-60 2376033H 8371-60 2384186H 8371-60 2387985H 8371-60 2395560H 8604-59 2360915H 8604-59 2369616H 8604-59 2377698H 8604-59 2380424H 8604-59 2391241H 8604-59 2393179H 8604-59 2394377H 8604-59 2398022H 8604-59 2398023H 8604-59 2400027H 8639-61 2400870H 8653-58 2362119H 8653-58 2373403H 8653-58 2385643H 8653-58 2389101H 8653-58 2392308H 8653-58 2395562H 8886-24 2319910H 8886-24 2361849H 8886-24 2369092H 8886-24 2390333H 8886-24 2393787H 8886-24 2402353H 9181-61 2385522H 9181-61 2395563H 9235-66 2363957H 9235-66 2370285H 9235-66 2375350H 9235-66 2380936H 9235-66 2390598H 9235-66 2392134H 9235-66 2394556H 9235-66 2396871H 9235-66 2398793H 9235-66 2400724H NVX-10008-14 JZ5030128 NVX-10008-14 JZ5030129 NVX-10008-15 JZ5031475 NVX-10008-15 JZ5031478 NVX-10008-15 JZ5031474 NVX-10008-15 JZ5031477 NVX-10008-15 JZ5031479 NVX-10008-15 JZ5031480 NVX-10008-15 JZ5031476 NVX-10391-04 JZ5040959 NVX-10477-18 JZ5042939 NVX-10477-18 JZ5037021 NVX-10477-18 JZ5036163 NVX-10477-18 JZ5036161 NVX-11016-11 JZ5040495 NVX-11016-11 JZ5039057 NVX-11016-11 JZ5030204 NVX-11017-09 JZ5040497 NVX-11017-09 JZ5039059 NVX-1179-43 JZ5039065 NVX-1179-43 JZ5035759 NVX-1179-43 JZ5035757 NVX-1179-43 JZ5035763 NVX-1179-43 JZ5035771 NVX-1179-43 JZ5035765 NVX-1179-43 JZ5035753 NVX-1179-43 JZ5035755 NVX-1179-43 JZ5035761 NVX-1179-43 JZ5035783 NVX-1179-43 JZ5035773 NVX-1179-43 JZ5035769 NVX-1179-43 JZ5035767 NVX-1179-43 JZ5035779 NVX-1179-43 JZ5035777 NVX-1179-43 JZ5035781 NVX-1179-43 JZ5035775 NVX-1179-43 JZ5035751 NVX-12609-07 JZ5040004 NVX-12609-07 JZ5037138 NVX-12622-13 JZ5039729 NVX-12622-13 JZ5039727 NVX-12622-13 JZ5037833 NVX-13001-15 JZ5039224 NVX-13157-07 JZ5041349 NVX-13157-07 JZ5037867 NVX-13235-16 JZ5029237 NVX-13235-16 JZ5029241 NVX-13235-16 JZ5029239 NVX-13235-17 JZ5032768 NVX-13235-17 JZ5032766 NVX-13235-17 JZ5037196 NVX-13235-17 JZ5037198 NVX-13235-17 JZ5036777 NVX-13235-17 JZ5036773 NVX-13235-17 JZ5036775 NVX-13512-08 JZ5036301 NVX-13512-10 JZ5041727 NVX-13512-10 JZ5041373 NVX-13512-10 JZ5037895 NVX-14569-06 JZ5042373 NVX-14569-06 JZ5041790 NVX-14569-06 JZ5041469 NVX-14716-01 JZ5029262 NVX-14716-02 JZ5040588 NVX-14716-02 JZ5040032 NVX-14764-06 JZ5033636 NVX-14764-07 JZ5043200 NVX-15134-06 JZ5038024 NVX-15134-06 JZ5030185 NVX-15134-06 JZ5030177 NVX-15134-06 JZ5030183 NVX-15134-06 JZ5030179 NVX-15134-06 JZ5030181 NVX-15286-08 JZ5041538 NVX-15286-08 JZ5029850 NVX-15286-08 JZ5029854 NVX-15286-08 JZ5029856 NVX-15286-08 JZ5029852 NVX-15286-08 JZ5029860 NVX-15286-08 JZ5029858 NVX-15562-05 JZ5042533 NVX-15562-05 JZ5038061 NVX-15562-05 JZ5030459 NVX-15698-06 JZ5040593 NVX-15698-06 JZ5038982 NVX-15857-11 JZ5039820 NVX-15857-11 JZ5037312 NVX-15857-11 JZ5036409 NVX-16003-09 JZ5042294 NVX-16003-09 JZ5042290 NVX-16003-09 JZ5042168 NVX-16003-09 JZ5042192 NVX-16003-09 JZ5042190 NVX-16003-09 JZ5042194 NVX-16003-09 JZ5042196 NVX-16003-09 JZ5042298 NVX-16003-09 JZ5042292 NVX-16003-09 JZ5042296 NVX-16003-09 JZ5029545 NVX-16019-07 JZ5041583 NVX-16019-07 JZ5041827 NVX-16019-07 JZ5038817 NVX-16019-07 JZ5038105 NVX-16088-03 JZ5035589 NVX-16088-03 JZ5035591 NVX-16088-03 JZ5035593 NVX-16088-03 JZ5035596 NVX-16088-03 JZ5035587 NVX-16088-03 JZ5035585 NVX-16088-03 JZ5035605 NVX-16088-03 JZ5035598 NVX-16088-03 JZ5035600 NVX-16088-03 JZ5035603 NVX-16200-11 JZ5042834 NVX-16200-11 JZ5042840 NVX-16200-11 JZ5039860 NVX-16200-11 JZ5038120 NVX-16200-11 JZ5038118 NVX-16382-04 JZ5042875 NVX-16382-04 JZ5042873 NVX-16382-04 JZ5040249 NVX-16382-04 JZ5040246 NVX-16382-04 JZ5040244 NVX-16382-04 JZ5040251 NVX-16382-04 JZ5040242 NVX-16382-04 JZ5039406 NVX-16382-04 JZ5039102 NVX-16382-04 JZ5019104 NVX-1765-62 JZ5029973 NVX-1765-62 JZ5029969 NVX-1765-62 JZ5029971 NVX-1765-62 JZ5029967 NVX-1765-62 JZ5029965 NVX-1765-63 JZ5040980 NVX-1765-63 JZ5040974 NVX-1765-63 JZ5040972 NVX-1765-63 JZ5040976 NVX-1765-63 JZ5040978 Q38631C 2387535H
• Recalling Firm/ Manufacturer: Alcon Research, LLC; 9965 Buffalo Speedway; Houston TX 77054-1309
• For Additional Information Contact: 713-668-9100
• Manufacturer Reason for Recall: The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Alcon sent their customers an Urgent Medical Device Advisory Letter via Fed-Ex overnight mail beginning on August 24, 2020. The letter notifies customers that Alcon has been informed by Cardinal Health that they have initiated a voluntary recall for specific production lots of Cardinal Health Protexis Latex Micro Surgical Gloves. Customers were informed of the following: records show their facility received Alcon Custom Pak(s) with the affected surgical gloves; the gloves may have a degradation defect which could lead to holes and donning tears around the cuff of the gloves; and that this may present a potential risk of infection or cross patient-clinician exposure to body fluids. Customers were informed that Cardinal Health has received complaints regarding this issue, but that neither Cardinal or Alcon have received any reports of injury or harm. Customers are requested to review storage and usage locations to confirm whether they have any affected, listed in an attachment to the notification letter, in stock. Customers were warned that they may receive additional affected product, packaged and shipped before the recall was initiated. Customers were instructed that upon opening affected Paks, gloves should be removed, segregated and disposed of to prevent their use. Customers are requested to forward the notice to all departments and organizations affected, and fill out and return the Response Form via Fax or email to Alcon at Fax: 817-302-4337 or Email: Market.Actions@a lcon.com even if no product is remaining in stock. Customers were informed that their accounts will be credited to compensate for unused gloves, and that other components in the Alcon Custom Paks are unaffected and may be used. Customers with questions should contact customer service at 1 800 862 5266, or contact their Alcon Sales Representative.
• Quantity in Commerce: 16,971 Paks
• Distribution: U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MN, MO, NE, NJ, NV, NY, OK, PA, TN, TX, UT, WA, WV.
• 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.

• 510(K) Database: 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES