Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Device Recall #Z-1328-2021 — Class II — February 2, 2021
Recall Summary
| Recall Number | Z-1328-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 2, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research, LLC |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 249,853 Custom Packs |
Product Description
Alcon Custom Ophthalmic Surgical Procedure Packs
Reason for Recall
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Distribution Pattern
Distribution US nationwide, including Puerto Rico; Canada, Australia, New Zealand, Mexico, Malaysia, and Thailand
Lot / Code Information
Lot Number Pak Number 2461031H 0012-61, 2461032H 0017-68, 2471522H 0017-69, 2470351H 0091-68, 2475039H 0091-69, 2477748H 0147-62, 2462158H 0148-63, 2460228H 0188-76, 2467978H 0204-58, 2462215H 0234-66, 2467189H 0234-66, 2469722H 0234-66, 2469576H 0235-74, 2471338H 0235-74, 2476349H 0235-74, 2456156H 0316-66, 2451430H 0365-74, 2464636H 0437-38, 2466614H 0437-38, 2469145H 0437-38, 2475934H 0437-38, 2478372H 0437-38, 2465722H 0472-56, 2451167H 0486-69, 2457152H 0486-69, 2468378H 0540-73, 2477328H 0540-74, 2457720H 0557-75, 2459855H 0557-75, 2465117H 0557-75, 2467632H 0557-75, 2471693H 0557-75, 2450010H 0562-64, 2452620H 0562-64, 2465723H 0562-64, 2472329H 0562-64, 2448882H 0587-88, 2449035H 0587-88, 2450960H 0587-88, 2470118H 0587-88, 2465724H 0607-57, 2470245H 0613-80, 2475040H 0613-80, 2459856H 0630-68, 2465118H 0630-68, 2471694H 0630-68, 2474352H 0630-68, 2476843H 0630-68, 2458037H 0633-57, 2463374H 0633-57, 2457722H 0650-75, 2465119H 0650-75, 2467633H 0650-75, 2463375H 0680-72, 2457723H 0720-71, 2465120H 0720-71, 2461039H 0721-59, 2467033H 0721-59, 2473703H 0721-60, 2458813H 0773-66, 2454401H 0774-65, 2465665H 0800-70, 2470205H 0800-70, 2461040H 0802-62, 2464915H 0802-62, 2467274H 0802-62, 2474132H 0802-62, 2457153H 0835-59, 2470095H 0847-86, 2470096H 0847-86, 2448883H 0849-75, 2450961H 0849-75, 2460231H 0849-75, 2470131H 0849-75, 2458038H 0888-68, 2475890H 0888-68, 2464512H 0933-71, 2469459H 0933-71, 2469460H 0933-71, 2473935H 0933-71, 2473936H 0933-71, 2469461H 0938-57, 2473937H 0938-58, 2457154H 0956-67, 2459858H 0979-64, 2477374H 10008-15, 2452698H 10014-60, 2465653H 10030-16, 2470316H 10030-16, 2470849H 10030-16, 2476257H 10039-17, 2443135H 1007-67, 2448974H 1007-67, 2450962H 1007-67, 2458399H 1007-67, 2459860H 10104-13, 2462847H 10104-13, 2465123H 10104-13, 2474357H 10104-13, 2464850H 10111-18, 2469645H 10111-18, 2476415H 10111-18, 2476416H 10111-18, 2462312H 1011-59, 2462593H 1011-59, 2449036H 10136-15, 2450963H 10136-15, 2458400H 10136-15, 2448940H 10142-16, 2450964H 10142-16, 2450965H 10178-15, 2456160H 1018-40, 2466488H 10222-21, 2466489H 10222-21, 2467118H 10222-21, 2469647H 10222-21, 2471549H 10222-21, 2476501H 10223-16, 2449134H 10229-17, 2464639H 10229-17, 2466618H 10229-17, 2469148H 10229-17, 2471390H 10229-17, 2475938H 10229-17, 2467191H 10264-15, 2469724H 10264-15, 2458815H 10300-15, 2458816H 10313-21, 2448884H 10325-27, 2448975H 10325-27, 2456412H 10325-27, 2458402H 10325-27, 2470085H 10325-27, 2470086H 10325-27, 2453702H 10335-11, 2473623H 10342-17, 2443820H 10355-22, 2452485H 10355-22, 2454442H 10355-22, 2477377H 10356-15, 2477378H 10356-15, 2450967H 10415-09, 2470322H 10431-12, 2461210H 10477-18, 2467502H 10483-13, 2469930H 10483-13, 2474283H 10483-13, 2470402H 10489-07, 2475076H 10498-08, 2454550H 10508-13, 2456609H 10508-13, 2431621H 10511-26, 2455356H 10511-26, 2472100H 10511-26, 2466620H 10515-02, 2469151H 10515-02, 2473771H 10515-02, 2475941H 10515-02, 2447582H 10516-16, 2452632H 10516-16, 2468034H 10516-16, 2454445H 10519-25, 2456415H 10519-25, 2470124H 10519-25, 2465036H 10535-13, 2467503H 10535-13, 2469931H 10535-13, 2454418H 1053-71, 2458406H 1053-71, 2470083H 1053-71, 2470084H 1053-71, 2462804H 1054-58, 2467504H 1054-58, 2464802H 10558-10, 2462373H 10560-13, 2462374H 10560-13, 2462805H 10560-13, 2465037H 10560-13, 2467505H 10560-13, 2467506H 10560-13, 2469932H 10560-13, 2469933H 10560-13, 2468336H 10568-12, 2461213H 10572-18, 2462708H 10572-18, 2464916H 10572-18, 2467275H 10572-18, 2469801H 10572-18, 2471391H 10577-13, 2462296H 10604-08, 2462537H 10604-08, 2466903H 10604-09, 2471286H 10604-09, 2473940H 10604-09, 2476258H 10604-09, 2473773H 10614-10, 2475944H 10614-10, 2467192H 10622-07, 2471569H 10622-07, 2477464H 10638-26, 2457241H 10663-08, 2476259H 10667-17, 2464803H 10673-05, 2476260H 10673-05, 2466561H 10676-16, 2475891H 10676-16, 2478314H 10695-11, 2453335H 10735-17, 2464643H 10735-18, 2469155H 10735-18, 2472332H 1074-75, 2446885H 10749-18, 2446886H 10749-18, 2446887H 10749-18, 2446888H 10749-18, 2446889H 10749-18, 2446890H 10749-18, 2446891H 10749-18, 2446892H 10749-18, 2465126H 10749-18, 2465128H 10749-18, 2467635H 10749-18, 2467637H 10749-18, 2467638H 10749-18, 2467640H 10749-18, 2467641H 10749-18, 2467642H 10749-18, 2474361H 10749-18, 2474362H 10749-18, 2474363H 10749-18, 2474364H 10749-18, 2457243H 10772-34, 2456418H 10775-22, 2458408H 10775-22, 2470092H 10775-22, 2450971H 10777-17, 2473775H 10782-27, 2475945H 10782-27, 2475946H 10782-27, 2477264H 10787-06, 2475013H 10788-18, 2459862H 1080-80, 2465130H 1080-80, 2467643H 1080-80, 2474365H 1080-80, 2461222H 10814-14, 2464645H 10814-14, 2469157H 10814-14, 2475947H 10814-14, 2475030H 10834-15, 2472356H 10841-09, 2452491H 10843-37, 2474949H 10845-11, 2465131H 10846-13, 2471700H 10846-13, 2471701H 10846-13, 2458143H 10850-11, 2464477H 10850-11, 2467037H 10850-11, 2474981H 10859-09, 2417400H 10868-17, 2420512H 10868-17, 2430895H 10868-17, 2435523H 10868-17, 2447767H 10868-17, 2463421H 10869-05, 2472922H 10869-05, 2475005H 10869-05, 2450275H 10875-20, 2462248H 10881-18, 2466906H 10904-28, 2469466H 10904-28, 2471482H 10904-28, 2473615H 10904-28, 2476261H 10904-28, 2448942H 10925-31, 2467038H 10929-13, 2476356H 10929-13, 2469467H 10931-10, 2463576H 10935-13, 2466908H 10939-10, 2461226H 10944-06, 2465038H 10976-12, 2472357H 11012-16, 2473776H 11027-16, 2472310H 11052-12, 2467828H 11053-08, 2470223H 11066-07, 2472358H 11080-09, 2477465H 11080-09, 2456226H 11093-18, 2469725H 11112-03, 2457707H 11124-17, 2464586H 11124-17, 2465597H 11124-17, 2470237H 11124-17, 2465632H 11126-10, 2465633H 11126-10, 2468037H 11126-10, 2470403H 11126-10, 2472283H 11126-10, 2472284H 11126-10, 2448924H 11127-18, 2450974H 11127-18, 2454448H 11127-18, 2456424H 11127-18, 2458412H 11127-18, 2463675H 11128-11, 2474056H 11128-12, 2476420H 11128-12, 2469106H 11156-09, 2454804H 11157-12, 2468498H 11157-12, 2461227H 11162-36, 2461228H 11162-36, 2464852H 11162-36, 2467119H 11162-36, 2469648H 11162-36, 2474018H 11164-20, 2461231H 11194-13, 2454449H 11196-20, 2463422H 11211-22, 2463423H 11211-22, 2463424H 11211-22, 2458152H 11215-16, 2458153H 11215-16, 2467040H 11215-16, 2469582H 11215-16, 2422791H 11220-20, 2424883H 11220-20, 2428477H 11220-20, 2428478H 11220-20, 2433442H 11220-20, 2462111H 11220-20, 2462192H 11220-20, 2469025H 11220-21, 2469468H 11220-21, 2469469H 11220-21, 2475087H 11220-21, 2475088H 11220-21, 2475089H 11220-21, 2471483H 11225-12, 2467875H 11230-24, 2470294H 11230-24, 2466627H 11253-10, 2469161H 11253-10, 2473779H 11253-10, 2475952H 11253-10, 2464628H 11254-30, 2443137H 11260-12, 2448885H 11260-12, 2448886H 11260-12, 2448979H 11260-12, 2473645H 11295-07, 2449750H 11311-07, 2465136H 11311-07, 2467814H 11311-07, 2467815H 11311-07, 2476845H 11311-07, 2465137H 11312-12, 2475843H 11318-07, 2475012H 11322-20, 2456229H 11325-17, 2476264H 11328-16, 2462673H 11335-21, 2467194H 11335-21, 2469726H 11335-21, 2469803H 11339-17, 2474133H 11339-17, 2474134H 11339-17, 2476564H 11339-17, 2478978H 11339-17, 2462383H 11340-11, 2466563H 11340-11, 2473681H 11340-11, 2475893H 11340-11, 2459801H 11347-08, 2464594H 11347-08, 2467195H 11347-08, 2469727H 11347-08, 2464648H 11350-15, 2473780H 11350-15, 2475953H 11350-15, 2455536H 11371-19, 2462675H 11371-20, 2464532H 11371-20, 2466542H 11371-20, 2467196H 11371-20, 2469728H 11371-20, 2471570H 11371-20, 2474099H 11371-20, 2448980H 11374-11, 2450977H 11374-11, 2458416H 11374-11, 2469729H 11389-09, 2456904H 11397-08, 2469583H 11397-08, 2465756H 11400-14, 2469472H 11400-14, 2477469H 11400-15, 2462384H 11401-12, 2466564H 11401-12, 2472360H 11401-12, 2475090H 11401-12, 2475794H 11401-13, 2479672H 11401-13, 2456232H 11411-16, 2461244H 11411-16, 2464649H 11411-16, 2466629H 11411-16, 2458156H 11426-23, 2477291H 11426-24, 2448943H 11429-18, 2449039H 11429-18, 2458417H 11429-18, 2470057H 11429-18, 2458418H 11430-13, 2463577H 11435-12, 2466912H 11439-15, 2471287H 11439-15, 2476265H 11439-15, 2467277H 11444-27, 2469804H 11444-27, 2469805H 11444-27, 2471591H 11444-27, 2474135H 11444-27, 2474136H 11444-27, 2476565H 11444-27, 2465541H 11449-13, 2465542H 11449-13, 2467840H 11449-13, 2454453H 11457-16, 2467278H 11458-19, 2471592H 11458-19, 2474137H 11458-19, 2476566H 11458-19, 2476266H 11466-21, 2461247H 11477-24, 2466630H 11477-25, 2466631H 11477-25, 2475956H 11481-26, 2475957H 11481-26, 2411646H 11484-14, 2424404H 11484-14, 2428872H 11484-15, 2428873H 11484-15, 2433445H 11484-15, 2433446H 11484-15, 2438406H 11484-15, 2440676H 11484-15, 2446466H 11484-15, 2446467H 11484-15, 2453460H 11484-15, 2453461H 11484-15, 2455461H 11484-16, 2455462H 11484-16, 2455463H 11484-16, 2455464H 11484-16, 2455465H 11484-16, 2455466H 11484-16, 2461249H 11484-16, 2461250H 11484-16, 2461251H 11484-16, 2461252H 11484-16, 2466914H 11484-16, 2469473H 11484-16, 2469474H 11484-16, 2471484H 11484-16, 2472230H 11484-16, 2472231H 11484-16, 2472232H 11484-16, 2439459H 11514-18, 2454455H 11514-18, 2463579H 11514-18, 2448944H 11515-19, 2449042H 11515-19, 2449043H 11515-19, 2452498H 11515-19, 2456430H 11515-19, 2456431H 11515-19, 2458423H 11515-19, 2470035H 11515-19, 2470036H 11515-19, 2470037H 11515-19, 2470038H 11515-19, 2452499H 11518-34, 2461258H 11525-16, 2464835H 11525-16, 2467042H 11525-16, 2469584H 11525-16, 2458162H 11527-07, 2452500H 11530-12, 2461265H 11545-28, 2464616H 11545-29, 2464618H 11545-29, 2464619H 11545-29, 2464620H 11545-29, 2459648H 11548-16, 2469649H 11548-16, 2456909H 11549-15, 2467121H 11549-15, 2469650H 11549-15, 2468040H 11556-11, 2451336H 11560-16, 2471571H 11574-23, 2452699H 11579-04, 2466915H 11579-04, 2469475H 11579-04, 2471485H 11579-04, 2473945H 11579-04, 2456911H 11580-09, 2461266H 11580-10, 2464558H 11580-10, 2466634H 11580-10, 2450357H 11602-25, 2450360H 11602-25, 2450362H 11602-25, 2450364H 11602-25, 2456436H 11607-29, 2458426H 11607-29, 2464601H 11608-26, 2467280H 11608-26, 2476568H 11608-26, 2476360H 11625-12, 2452700H 11639-16, 2452701H 11639-16, 2452702H 11639-16, 2452703H 11639-16, 2452704H 11639-16, 2452705H 11639-16, 2452706H 11639-16, 2477249H 11652-03, 2474990H 11663-07, 2456913H 11668-04, 2461278H 11668-04, 2443831H 11669-16, 2465709H 11669-16, 2458962H 11675-15, 2462423H 11675-16, 2464497H 11675-16, 2472923H 11681-10, 2472924H 11681-10, 2477472H 11692-06, 2462343H 11724-25, 2467043H 11736-15, 2474020H 11736-15, 2476361H 11736-15, 2463681H 11739-14, 2467044H 11739-14, 2469586H 11739-14, 2474021H 11739-14, 2476362H 11741-12, 2466636H 11757-09, 2469167H 11757-09, 2475965H 11757-09, 2462425H 11764-10, 2464654H 11764-10, 2466637H 11764-11, 2469168H 11764-11, 2475966H 11764-11, 2450377H 11775-13, 2468041H 11776-16, 2450380H 11777-14, 2468042H 11777-14, 2456782H 1177-76, 2469169H 11786-01, 2475967H 11786-01, 2456161H 1179-43, 2456162H 1179-43, 2457155H 1179-43, 2467932H 1179-44, 2467933H 1179-44, 2470339H 1179-44, 2470340H 1179-44, 2464918H 11802-07, 2467281H 11802-07, 2469806H 11802-07, 2475878H 11802-07, 2468484H 11807-10, 2443264H 11819-21, 2454462H 11819-21, 2459372H 11819-21, 2463582H 11819-21, 2457255H 11839-12, 2463428H 11892-19, 2464919H 11910-30, 2467283H 11910-30, 2469808H 11910-30, 2476569H 11910-30, 2462711H 11912-25, 2464602H 11912-25, 2467284H 11912-25, 2456236H 11913-21, 2461283H 11913-21, 2467285H 11913-21, 2479814H 11915-16, 2463429H 11916-07, 2457733H 1191-71, 2465139H 1191-71, 2467858H 11922-04, 2474941H 11922-04, 2473786H 11938-11, 2475968H 11938-11, 2462121H 11949-19, 2464595H 11949-19, 2467201H 11949-19, 2469733H 11949-19, 2473673H 11949-19, 2439467H 11954-17, 2439468H 11954-17, 2473658H 11958-07, 2452264H 11959-17, 2452265H 11959-17, 2469172H 11975-08, 2475970H 11975-08, 2470326H 11984-18, 2443124H 11998-13, 2448926H 11998-13, 2450982H 11998-13, 2456442H 11998-13, 2458430H 11998-13, 2470101H 11998-13, 2464920H 12001-08, 2474144H 12001-08, 2475008H 12001-08, 2477477H 12001-08, 2446469H 12021-12, 2465759H 12021-12, 2464896H 12034-20, 2467202H 12034-20, 2469734H 12034-20, 2471572H 12034-21, 2463431H 12045-15, 2474287H 12047-14, 2465589H 1204-83, 2465590H 1204-83, 2465591H 1204-83, 2465592H 1204-83, 2449754H 12049-16, 2471710H 12049-16, 2474371H 12049-16, 2452639H 12076-04, 2461284H 12076-04, 2464657H 12078-04, 2466640H 12078-04, 2469173H 12078-04, 2473787H 12078-04, 2461286H 12084-14, 2472289H 12090-10, 2465142H 12095-11, 2463432H 12102-14, 2467906H 12102-14, 2470198H 12102-14, 2458044H 1210-68, 2458045H 1210-68, 2467982H 1210-68, 2467983H 1210-68, 2470252H 1210-68, 2470253H 1210-68, 2470254H 1210-68, 2446565H 12107-11, 2462628H 12107-11, 2467123H 12107-11, 2469652H 12107-11, 2474061H 12107-12, 2467902H 12119-09, 2468381H 12119-09, 2468382H 12119-09, 2466543H 12120-14, 2469735H 12120-14, 2477279H 12124-15, 2468408H 12125-05, 2450411H 12128-08, 2456241H 12128-08, 2454814H 12129-18, 2448945H 12149-22, 2450983H 12149-23, 2472362H 12151-06, 2474976H 12151-06, 2463433H 12153-14, 2463434H 12153-14, 2471399H 12153-14, 2475092H 12153-14, 2475093H 12153-14, 2475971H 12153-14, 2468044H 12164-17, 2470421H 12164-17, 2472301H 12164-17, 2462429H 12185-14, 2462135H 12187-06, 2473789H 12187-06, 2475094H 12187-06, 2477310H 12187-06, 2454464H 12192-14, 2456443H 12192-14, 2464855H 12193-11, 2469653H 12193-11, 2457735H 12202-13, 2459869H 12202-13, 2465143H 12202-13, 2467648H 12202-13, 2463584H 12209-17, 2473947H 12231-09, 2468385H 12245-09, 2468461H 12246-13, 2422671H 12255-16, 2430802H 12255-16, 2434668H 12255-16, 2449145H 12255-16, 2462430H 12255-17, 2464658H 12255-17, 2466642H 12255-17, 2469175H 12255-17, 2470847H 12255-17, 2471237H 12255-18, 2475096H 12255-18, 2471487H 12290-14, 2441761H 12295-11, 2461290H 12295-11, 2458967H 12309-11, 2459620H 12309-12, 2461291H 12309-12, 2462386H 12309-12, 2464466H 12309-12, 2416628H 12326-20, 2419351H 12326-20, 2420837H 12326-20, 2427091H 12326-20, 2436853H 12326-20, 2439469H 12326-20, 2452504H 12326-20, 2458432H 12326-20, 2460265H 12326-20, 2470422H 12334-09, 2463683H 12343-10, 2466918H 12343-10, 2470423H 12343-10, 2471331H 12343-10, 2476269H 12343-11, 2446900H 12345-11, 2446901H 12345-11, 2459873H 12345-11, 2459874H 12345-11, 2465147H 12345-11, 2467649H 12345-11, 2471715H 12345-11, 2474376H 12345-11, 2476848H 12345-11, 2471401H 12346-08, 2459877H 12354-14, 2462857H 12354-14, 2465148H 12354-14, 2470424H 12359-13, 2475097H 12359-14, 2461293H 12377-06, 2464856H 12377-06, 2469654H 12377-06, 2475098H 12394-03, 2450984H 12400-14, 2456444H 12403-13, 2473910H 12414-09, 2458971H 12415-13, 2470425H 12420-20, 2467204H 12423-26, 2467205H 12423-26, 2464660H 12429-06, 2466644H 12429-06, 2469178H 12429-06, 2475973H 12429-06, 2461294H 12433-14, 2465150H 12451-09, 2467650H 12451-09, 2471721H 12451-09, 2463585H 12452-11, 2463438H 12457-11, 2412962H 12459-09, 2415246H 12459-09, 2417933H 12459-09, 2422795H 12459-09, 2428876H 12459-09, 2431147H 12459-09, 2436106H 12459-09, 2443922H 12459-09, 2446471H 12459-09, 2449301H 12459-09, 2459597H 12459-10, 2462193H 12459-10, 2466920H 12459-10, 2469026H 12459-11, 2475099H 12459-11, 2468448H 12461-03, 2437459H 12475-09, 2463685H 12480-05, 2470354H 1249-62, 2476270H 1249-62, 2461296H 12498-07, 2464518H 12498-07, 2469480H 12498-07, 2456244H 12519-10, 2456446H 12530-08, 2464467H 12557-05, 2466568H 12557-05, 2459687H 12558-11, 2464661H 12558-11, 2466645H 12558-11, 2469179H 12558-11, 2449470H 12569-11, 2452268H 12569-11, 2467870H 12569-12, 2468603H 12576-03, 2467651H 1258-69, 2466531H 12591-13, 2469482H 12591-13, 2473948H 12591-13, 2449045H 12600-23, 2456450H 12600-23, 2470104H 12600-23, 2473949H 12604-08, 2477482H 12609-08, 2466923H 12610-06, 2469484H 12610-06, 2473950H 12610-06, 2461298H 12612-05, 2465762H 12612-05, 2466569H 12612-05, 2473659H 12612-05, 2474918H 12612-05, 2475894H 12612-05, 2477483H 12612-05, 2464459H 12614-07 2468047H 12630-07 2465763H 12637-12 2466924H 12637-12 2469485H 12637-12 2471489H 12637-12 2473951H 12637-12 2465764H 12643-04 2467866H 12643-04 2467867H 12643-04 2427264H 12647-08 2427267H 12647-08 2427269H 12647-08 2427273H 12647-08 2456928H 12647-08 2456929H 12647-08 2468379H 12651-05 2461300H 12652-13 2472901H 12657-18 2452272H 12673-14 2468172H 12693-05 2468604H 12693-05 2473125H 12693-05 2456931H 12699-09 2462433H 12700-21 2466647H 12700-21 2469181H 12700-21 2471238H 12700-22 2471279H 12700-22 2458175H 12706-06 2462387H 12706-06 2463687H 12706-06 2470471H 12706-06 2473953H 12709-09 2464857H 12711-03 2467125H 12711-03 2469655H 12711-03 2473641H 12711-03 2476427H 12711-03 2461303H 12716-12 2465546H 12716-12 2471378H 12716-12 2473744H 12716-12 2475895H 12716-12 2463445H 12724-15 2463446H 12724-15 2433829H 12726-14 2450435H 12726-14 2463688H 12726-15 2469110H 12726-16 2463448H 12736-09 2465630H 12736-09 2470865H 1273-72 2457273H 12739-18 2447622H 12743-04 2449307H 12743-04 2466927H 12743-04 2469079H 12743-04 2468350H 12746-14 2470741H 12746-14 2461304H 12757-16 2469489H 12757-17 2469490H 12757-17 2469491H 12757-17 2473956H 12757-17 2473957H 12757-17 2476277H 12757-17 2476278H 12757-17 2476279H 12757-17 2471725H 12761-14 2446613H 12762-12 2462344H 12762-13 2462679H 12762-13 2464898H 12762-13 2467207H 12762-13 2469739H 12762-13 2474104H 12762-13 2476510H 12762-13 2468048H 12768-06 2470771H 12768-06 2477313H 12768-06 2431812H 12770-05 2442314H 12770-05 2457275H 12770-05 2474903H 12770-05 2456452H 12774-22 2458446H 12774-22 2463689H 12810-28 2466934H 12810-28 2469492H 12810-28 2476280H 12810-28 2463587H 12811-15 2453469H 12813-09 2456248H 12813-09 2456249H 12813-09 2462548H 12813-09 2464805H 12813-09 2466935H 12813-09 2469493H 12813-09 2457277H 12838-10 2470472H 12838-10 2474935H 12838-10 2477485H 12838-10 2436091H 12858-19 2441498H 12858-19 2448983H 12858-19 2450989H 12858-19 2456457H 12858-19 2458449H 12858-19 2457158H 1291-63 2467208H 1291-63 2469740H 1291-63 2471574H 1291-63 2464836H 1292-60 2467046H 1292-60 2457280H 12931-13 2461313H 12931-13 2466497H 12931-13 2467861H 12934-07 2470342H 12934-07 2472928H 12934-07 2472367H 12942-16 2458450H 12956-13 2465708H 12956-13 2459645H 12959-10 2467047H 12959-10 2469587H 12959-10 2477245H 12975-11 2476681H 12994-17 2416634H 12996-13 2419362H 12996-13 2434981H 12996-13 2436864H 12996-13 2441499H 12996-13 2454472H 12996-13 2472095H 12996-13 2465652H 1299-62 2470228H 1299-62 2470229H 1299-62 2461315H 13001-16 2477241H 13001-17 2477311H 13015-06 2469495H 1301-63 2471492H 1301-63 2473606H 1301-64 2468050H 13025-10 2468477H 13025-10 2457285H 13044-26 2455449H 13049-09 2464664H 13049-09 2469183H 13049-09 2466649H 13050-11 2466650H 13050-11 2469184H 13050-11 2469185H 13050-11 2462299H 13052-07 2466937H 13052-07 2469496H 13052-07 2473961H 13052-07 2453310H 13054-03 2456945H 13054-03 2462550H 13057-07 2469497H 13057-07 2473962H 13057-08 2470726H 13058-12 2470866H 13058-12 2456461H 13079-17 2458479H 13079-17 2465706H 13079-17 2452512H 13083-33 2456462H 13083-33 2458495H 13083-33 2470109H 13091-12 2470473H 13099-10 2472281H 13099-10 2468362H 13104-04 2468450H 13111-10 2473670H 13112-09 2475830H 13112-09 2446166H 13122-13 2466939H 13122-13 2473963H 13122-13 2446167H 13128-08 2466940H 13128-09 2471332H 13128-09 2473964H 13128-09 2476283H 13128-09 2468455H 13138-13 2452513H 13140-10 2454474H 13140-10 2464665H 13148-09 2469187H 13148-09 2475003H 13148-09 2453728H 13153-04 2471256H 13153-06 2451168H 13157-08 2468591H 13157-08 2470202H 13157-08 2463692H 13158-09 2470277H 13158-09 2474926H 13158-09 2457288H 13159-11 2468467H 13159-11 2449992H 13189-15 2450006H 13189-15 2476849H 13200-08 2467955H 13204-18 2470474H 13204-18 2446338H 13211-09 2466652H 13211-10 2470475H 13214-18 2466506H 13215-08 2469656H 13215-08 2471552H 13215-08 2456949H 13226-12 2466941H 13226-13 2450452H 13228-14 2450453H 13228-14 2446478H 13232-04 2449314H 13232-04 2465768H 13250-08 2466544H 13254-04 2469040H 13254-04 2470329H 13254-04 2457292H 13260-03 2464578H 13272-04 2473965H 13272-04 2476287H 13272-04 2462780H 13299-14 2465014H 13299-15 2468435H 13300-10 2468436H 13300-10 2467918H 13323-04 2463632H 1332-75 2472226H 1332-76 2472227H 1332-76 2464666H 13338-09 2466653H 13338-09 2469188H 13338-09 2475983H 13338-09 2456467H 13342-19 2458509H 13342-19 2470129H 13342-19 2464667H 13347-08 2471318H 13347-08 2473797H 13347-08 2475984H 13347-08 2465574H 13380-07 2470274H 13380-07 2469809H 13403-13 2471356H 13403-13 2476572H 13403-13 2468324H 13420-07 2477487H 13420-07 2468053H 13447-04 2456953H 13449-06 2456954H 13449-06 2464858H 13449-06 2467126H 13449-06 2467127H 13449-06 2469657H 13449-06 2471553H 13449-06 2459413H 13455-09 2459414H 13455-09 2459415H 13455-09 2459416H 13455-09 2459417H 13455-09 2459418H 13455-09 2459421H 13455-09 2463256H 13455-09 2468674H 13455-09 2468675H 13455-09 2468676H 13455-09 2468677H 13455-09 2468678H 13455-09 2468679H 13455-09 2468680H 13455-09 2468681H 13455-09 2468682H 13455-09 2468683H 13455-09 2468684H 13455-09 2452275H 13459-06 2475106H 13463-08 2449011H 13470-06 2470477H 13470-06 2474953H 13470-06 2446061H 13472-07 2462631H 13472-08 2467128H 13472-08 2469658H 13472-08 2469904H 13478-11 2467441H 13481-12 2469905H 13481-12 2450461H 13489-11 2467943H 13489-11 2467927H 13512-11 2446125H 13514-10 2461323H 13514-10 2471404H 13514-11 2475107H 13514-11 2475985H 13514-11 2449378H 13517-16 2469084H 13517-17 2471528H 13517-17 2473671H 13517-17 2476367H 13517-17 2464669H 13520-07 2466655H 13520-08 2468054H 13531-24 2470478H 13531-24 2468055H 13546-11 2457741H 13552-08 2457742H 13552-08 2459885H 13552-08 2465154H 13552-08 2465155H 13552-08 2467653H 13552-08 2467654H 13552-08 2467655H 13552-08 2471657H 13553-08 2473734H 13553-08 2462597H 13554-06 2476369H 13557-15 2459812H 13564-06 2462714H 13564-06 2464560H 13578-15 2463455H 13592-13 2450468H 13594-08 2468056H 13594-08 2475987H 13611-07 2467934H 1361-69 2443287H 13618-13 2456470H 13639-06 2458513H 13639-06 2449106H 13644-06 2462391H 13644-07 2462392H 13644-07 2466455H 13644-08 2466456H 13644-08 2469113H 13644-08 2475898H 13644-08 2458189H 13656-05 2465770H 13656-05 2470480H 13656-05 2472369H 13656-05 2457298H 13663-06 2459322H 13663-06 2465549H 13663-07 2449471H 13667-10 2463456H 13667-10 2470481H 13667-10 2475108H 13667-11 2470140H 13687-05 2470142H 13687-05 2459887H 13708-09 2463457H 13727-08 2458190H 13728-12 2458191H 13728-12 2458192H 13728-12 2458193H 13728-12 2468605H 13733-01 2468606H 13733-01 2468607H 13733-01 2473126H 13733-01 2462438H 13734-06 2469192H 13734-06 2475988H 13734-06 2466658H 13753-04 2469193H 13753-04 2473799H 13753-04 2459582H 13767-13 2461324H 13767-13 2464670H 13767-13 2466659H 13767-13 2475825H 13767-14 2456613H 13771-05 2459888H 13779-07 2465156H 13779-07 2467657H 13779-07 2443018H 13781-12 2461446H 13781-12 2461447H 13781-12 2472235H 13790-22 2472236H 13790-22 2472237H 13790-22 2461325H 13803-10 2461326H 13803-10 2464671H 13803-10 2466660H 13803-10 2466661H 13803-10 2475009H 13806-07 2446638H 13808-07 2449511H 13808-07 2467288H 13808-07 2467289H 13808-07 2469810H 13808-07 2471596H 13808-07 2473719H 13808-07 2473720H 13808-07 2474146H 13808-07 2476573H 13808-07 2476574H 13808-07 2469194H 13809-12 2471407H 13809-12 2458196H 13819-09 2449768H 13820-05 2457745H 13820-05 2459898H 13820-05 2461448H 13820-05 2463459H 13832-12 2456259H 13834-06 2470850H 13838-10 2470851H 13838-10 2475109H 13850-09 2470727H 13869-07 2472370H 13869-07 2468460H 13871-06 2415260H 13872-10 2426451H 13872-10 2428879H 13872-10 2428880H 13872-10 2428881H 13872-10 2431161H 13872-10 2431162H 13872-10 2449318H 13872-10 2449319H 13872-10 2453256H 13872-10 2453257H 13872-10 2455527H 13872-10 2455528H 13872-10 2455716H 13872-10 2455717H 13872-10 2461331H 13872-10 2461332H 13872-10 2461333H 13872-10 2461334H 13872-10 2463694H 13872-10 2463695H 13872-10 2469502H 13872-10 2469503H 13872-10 2470782H 13872-10 2470783H 13872-10 2470784H 13872-10 2470785H 13872-10 2470786H 13872-10 2475110H 13872-10 2475111H 13872-10 2475112H 13872-10 2477491H 13893-23 2466945H 13899-04 2469028H 13899-04 2473616H 13899-04 2475828H 13899-04 2464673H 13900-08 2469195H 13900-08 2452467H 1390-70 2469504H 1394-65 2473966H 1394-65 2467972H 13952-10 2470330H 13952-10 2461336H 13954-09 2464579H 13954-09 2471494H 13954-09 2476291H 13954-09 2450493H 13955-08 2477303H 13955-08 2450494H 13978-06 2463590H 13996-12 2441511H 13997-13 2459423H 13997-13 2443850H 13998-15 2468059H 14000-03 2470485H 14000-03 2457305H 14006-10 2467944H 14006-10 2465625H 14015-12 2467836H 14015-12 2467837H 14015-12 2467838H 14015-12 2467844H 14016-21 2462632H 1401-71 2464590H 1401-71 2467129H 1401-71 2453808H 14022-15 2453809H 14022-15 2471735H 14022-15 2471736H 14022-15 2452518H 14031-15 2467941H 14035-05 2470260H 14035-05 2452650H 14044-05 2465547H 14044-05 2467868H 14047-14 2473967H 14057-09 2473968H 14057-09 2446169H 14058-08 2459749H 14058-08 2464809H 14058-08 2471495H 14058-08 2473969H 14058-08 2475113H 14058-08 2449322H 14059-08 2466948H 14059-08 2469507H 14059-08 2477256H 14072-11 2456480H 14074-04 2458521H 14074-04 2467055H 14082-11 2477493H 14082-12 2465015H 14103-10 2467442H 14103-10 2450500H 14107-07 2458522H 14117-10 2469590H 14125-07 2463696H 14129-08 2474982H 14129-08 2444616H 14137-09 2446261H 14137-09 2446793H 14137-09 2452714H 14137-09 2469940H 14137-09 2471658H 14137-10 2471659H 14137-10 2423321H 14140-08 2425344H 14140-08 2463591H 14140-08 2471347H 14155-17 2475857H 14155-17 2452519H 14180-08 2456483H 14180-08 2471743H 14182-10 2474387H 14182-10 2479453H 14182-10 2446485H 14189-06 2461345H 14189-06 2466949H 14189-06 2469508H 14189-06 2471496H 14189-06 2476293H 14189-06 2467824H 14196-08 2453733H 14200-20 2453734H 14200-20 2453735H 14200-20 2469941H 14200-21 2469942H 14200-21 2469943H 14200-21 2461347H 14202-09 2470263H 14202-09 2464447H 14205-08 2464621H 14208-11 2471660H 14208-11 2463705H 14219-19 2469592H 14219-19 2472937H 14245-09 2477494H 14256-16 2470487H 14259-05 2477319H 14259-05 2457307H 14261-10 2464838H 14261-10 2467057H 14261-10 2469593H 14261-10 2467948H 14266-16 2446486H 14279-04 2464811H 14279-04 2466951H 14279-04 2469509H 14279-04 2473970H 14279-05 2446487H 14280-03 2469510H 14280-03 2476294H 14280-04 2477326H 14288-03 2463376H 1429-67 2463377H 1429-67 2465773H 14297-07 2467058H 14309-06 2469594H 14309-06 2450511H 14318-14 2470762H 14318-14 2470763H 14318-14 2470764H 14318-14 2470883H 14318-14 2470884H 14318-14 2470885H 14318-14 2456972H 14335-08 2457311H 14348-02 2417350H 14353-12 2427304H 14353-12 2433099H 14353-12 2435441H 14353-12 2444097H 14353-12 2462209H 14353-12 2467059H 14353-12 2469595H 14353-12 2471530H 14353-12 2474902H 14353-13 2476371H 14353-13 2477261H 14353-13 2424417H 14364-10 2435389H 14364-11 2443955H 14364-13 2448911H 14364-13 2455719H 14364-13 2462558H 14364-13 2464812H 14364-13 2466952H 14364-13 2469511H 14364-13 2473971H 14364-13 2456973H 14366-07 2456486H 14367-09 2459906H 14368-09 2459907H 14368-09 2457710H 14371-06 2464597H 14371-06 2465543H 14371-06 2451823H 14389-08 2467965H 1440-61 2467966H 1440-61 2467929H 14411-14 2468404H 14411-14 2469596H 14423-07 2464581H 14429-07 2466953H 14429-07 2469512H 14429-07 2446488H 14434-04 2466954H 14434-05 2469513H 14434-05 2473973H 14434-05 2476296H 14434-05 2462218H 14445-04 2472372H 14445-04 2461451H 14451-13 2465164H 14451-13 2465165H 14451-13 2465166H 14451-13 2467665H 14451-13 2467666H 14451-13 2462601H 14474-10 2469514H 14475-05 2465774H 14478-01 2468064H 14478-01 2470489H 14478-01 2446531H 14484-08 2467061H 14484-08 2467062H 14484-08 2467063H 14484-08 2469598H 14484-08 2469599H 14484-08 2468494H 14493-05 2463469H 14496-08 2463470H 14496-08 2465567H 14496-08 2470841H 14496-08 2477295H 14496-08 2452521H 14497-18 2446533H 14498-09 2461353H 14498-09 2467064H 14498-10 2467879H 14499-10 2477498H 14499-10 2440426H 14512-07 2446919H 14512-07 2449778H 14512-07 2451660H 14512-07 2453819H 14512-07 2457757H 14512-07 2459911H 14512-07 2462871H 14512-07 2465168H 14512-07 2467667H 14512-07 2471755H 14512-07 2474397H 14512-07 2463595H 14523-13 2438742H 14524-14 2442981H 14524-14 2443291H 14524-14 2462681H 14526-16 2469743H 14526-16 2476514H 14526-16 2468329H 14531-02 2468330H 14531-02 2417563H 14533-15 2419876H 14533-15 2424517H 14533-15 2429537H 14533-15 2429694H 14533-15 2470728H 14533-15 2472940H 14533-15 2441518H 14535-08 2471757H 14540-06 2474398H 14540-06 2471758H 14541-15 2474399H 14541-15 2477246H 14544-07 2475116H 14547-10 2475117H 14547-10 2477500H 14547-10 2440429H 14549-06 2462873H 14549-06 2467668H 14549-06 2446191H 14555-05 2469600H 14555-06 2476376H 14555-06 2446280H 14558-09 2462393H 14558-10 2466575H 14558-10 2473746H 14558-10 2475901H 14558-10 2446922H 14577-08 2474400H 14577-08 2476852H 14577-08 2476377H 14587-03 2447646H 14591-12 2468412H 14591-12 2468065H 14592-14 2462301H 14601-08 2469515H 14601-08 2473974H 14601-08 2476297H 14601-08 2466576H 14606-12 2471262H 14606-12 2450519H 14610-11 2450486H 14611-14 2450520H 14611-14 2459622H 14638-12 2464629H 14638-12 2469117H 14639-13 2461354H 14642-08 2461355H 14642-08 2462607H 14642-08 2462608H 14642-08 2467069H 14642-08 2469602H 14642-08 2474105H 14643-08 2463471H 14666-09 2467964H 14666-09 2468480H 14667-13 2471341H 14677-07 2476379H 14677-07 2468390H 14682-07 2465178H 14686-12 2471766H 14686-12 2471767H 14686-12 2474403H 14686-12 2476853H 14686-13 2476854H 14686-13 2477512H 14696-12 2477513H 14696-12 2468392H 14698-07 2469605H 14699-08 2479888H 14699-09 2467671H 14713-05 2474404H 14713-05 2474921H 14716-02 2450529H 14719-08 2462561H 14719-09 2475026H 14719-09 2453265H 14734-07 2455583H 14734-07 2476380H 14734-08 2449057H 14739-07 2451002H 14739-07 2454489H 14739-07 2456494H 14739-07 2458527H 14739-07 2457763H 14742-11 2457764H 14742-11 2457765H 14742-11 2457766H 14742-11 2459919H 14742-11 2459920H 14742-11 2461452H 14742-11 2465179H 14742-11 2465180H 14742-11 2467672H 14742-11 2467673H 14742-11 2461358H 14744-10 2468374H 14754-10 2468337H 14762-07 2467851H 14763-07 2467852H 14763-07 2468358H 14764-07 2468359H 14764-07 2470753H 14764-07 2456989H 14773-02 2461360H 14773-02 2468497H 14775-17 2474931H 14775-17 2473699H 14778-06 2461043H 1478-63 2456496H 14797-09 2458528H 14797-09 2470032H 14797-09 2470033H 14797-09 2470034H 14797-09 2454560H 14798-06 2456615H 14798-06 2466668H 14826-04 2471497H 14827-06 2473976H 14827-06 2464925H 14834-09 2471598H 14834-09 2475879H 14834-10 2456616H 14837-14 2462219H 14854-08 2475006H 14854-08 2472943H 14864-10 2446931H 14894-08 2449786H 14894-08 2459921H 14894-08 2459922H 14894-08 2462876H 14894-08 2465182H 14894-08 2467674H 14894-08 2467675H 14894-08 2474407H 14894-08 2474408H 14894-08 2453352H 14895-03 2468068H 14902-08 2472291H 14902-08 2472292H 14902-08 2470493H 14903-07 2464814H 14913-07 2456991H 14916-03 2462376H 14929-08 2468335H 14944-15 2475122H 14944-15 2477519H 14944-15 2472944H 14947-08 2467834H 14963-07 2477275H 14963-07 2450541H 14964-11 2477316H 14964-12 2449111H 14976-06 2466578H 14976-06 2469118H 14976-06 2473603H 14976-07 2475906H 14976-07 2477520H 14986-12 2465585H 14989-04 2467862H 14989-04 2467133H 14998-04 2469663H 14998-04 2472221H 15005-07 2472222H 15005-07 2472223H 15005-07 2475123H 15005-07 2475124H 15005-07 2475125H 15005-07 2458213H 15010-07 2460516H 15010-07 24
Other Recalls from Alcon Research, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1606-2024 | Class II | Various Alcon Custom Paks Surgical Procedure Pa... | Mar 15, 2024 |
| Z-1370-2024 | Class II | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, p... | Feb 21, 2024 |
| Z-0260-2024 | Class II | Alcon Custom-Pak, Surgical Procedure Pack REF 1... | Sep 7, 2023 |
| Z-0099-2024 | Class II | Constellation Vision System, REF: 8065751150 | Aug 18, 2023 |
| Z-1291-2023 | Class II | Alcon Custom Pak Surgical Procedure Pack: Pak ... | Mar 10, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.