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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Custom Pak

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  Class 2 Device Recall Alcon Custom Pak see related information
Date Initiated by Firm March 15, 2024
Date Posted April 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1606-2024
Recall Event ID 94253
510(K)Number K880961  
Product Classification General surgery tray - Product Code LRO
Product Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL
Code Information Pak Number/Product Desp/GTIN/UDI: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 380655168448 H5301ALCON1CPAK10 Lot Numbers: JZ5201911 JZ5202956 0752-74 CATARACT V A MED CTR 380653425277 H5301ALCON1CPAK10 Lot Numbers: JZ5180248 JZ5181442 JZ5193970 JZ5199465 JZ5200775 16JYUR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 380651661752 H5301ALCON1CPAK10 Lot Numbers: JZ5180968 15XVDX JZ5185253 JZ5186896 JZ5189654 JZ5194999 JZ5195815 JZ5200769 JZ5201588 11401-13 CATARACT SUTTER SOLANO MED CTR 380651681347 H5301ALCON1CPAK10 Lot Numbers: 160RRK 163XWD 165YVA 1681H3 169RYX 16A4UF 16KACN 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 380655151587 H5301ALCON1CPAK10 Lot Numbers: 15UXH3 15W9DE 15XE9V 15YE10 1628K4 1646KW 1657E6 1687N8 169J7K 16AHR0 16D2VP 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 380655158135 H5301ALCON1CPAK10 Lot Numbers: 15UWHC 15VAEH 15VWP3 15WC2N 15YJRJ 15YJT2 15YJTA 15YJTD 15YLT6 15YLT7 15YLV0 15YLWE 164R3F 1681HR 1683U4 1689KU 1689LH 169T02 16AUVP 16C497 16EE2D 16EE31 16EHCT 16JWXT 16KKDF 16KR3J 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 380655156513 H5301ALCON1CPAK10 Lot Numbers: 161CX3 164057 12185-14 CATARACT LASERVUE EYE CENTER 380651662698 H5301ALCON1CPAK10 Lot Numbers: 161HT2 166DNN 166DPV 167XAY 168J0C 16D31W 16FVYU 16JLLM 12213-12 CATARACT TULSA SPINE AND SPECIALTY 380655142332 H5301ALCON1CPAK10 Lot Numbers: JZ5180099 JZ5180703 JZ5182416 12213-13 CATARACT TULSA SPINE AND SPECIALTY 380655159736 H5301ALCON1CPAK10 Lot Numbers: JZ5194624 JZ5186533 JZ5190784 JZ5195054 12213-15 CATARACT TULSA SPINE AND SPECIALTY 380655167045 H5301ALCON1CPAK10 Lot Number: 16DY06 12213-16 CATARACT TULSA SPINE AND SPECIALTY 380655168899 H5301ALCON1CPAK10 Lot Numbers: 16JCD3 JZ5205295 16JYW4 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 380655142530 H5301ALCON1CPAK10 Lot Numbers: JZ5179405 JZ5179791 JZ5179793 15UMDX JZ5183399 JZ5185544 161WC3 JZ5185546 164NV6 166CF1 166CF6 169K47 169VJC 16AYM1 16EP3E 16ERDY 16H78W 16H7A0 16JJ75 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 380655151082 H5301ALCON1CPAK10 Lot Numbers: 15VJUE 161A9X 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 380655136058 H5301ALCON1CPAK10 Lot Number: 168F5E 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 380655169681 H5301ALCON1CPAK10 Lot Number: 16F8PN 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 380655148365 H5301ALCON1CPAK10 Lot Numbers: JZ5180061 15UTNR 15VP7K JZ5182727 JZ5183496 1641VT 164PYY 1664DR 166KMA 167VJ2 168PW9 169NKL 169NKN 16AUX1 16D31C 16D3EU 16ENFD JZ5200243 JZ5200239 JZ5201252 16FC7K 16FD6A 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 380651661653 H5301ALCON1CPAK10 Lot Numbers: 15V7VC 15YTL0 16EK48 16HV9P 16KTDN 16KV3J 13970-11 CATARACT GWINNETT CTR OUTPT SURG 380655153581 H5301ALCON1CPAK10 Lot Numbers: JZ5180411 JZ5180409 13970-12 CATARACT GWINNETT CTR OUTPT SURG 380655163511 H5301ALCON1CPAK10 Lot Numbers: JZ5195307 JZ5195305 16ACFA 16CW8X 16E005 16F3H9 JZ5201679 JZ5201681 JZ5202345 JZ5202347 16H4C7 16HCD2 14389-08 INFINITI STAMFORD SURGICAL CENTER 380653418811 H5301ALCON1CPAK10 Lot Numbers: 16ANV6 16EE39 14408-12 E-Z PACK QUEEN OF THE VALLEY 380651699090 H5301ALCON1CPAK10 Lot Numbers: 1637KP 163A2K 163A2L 1654AX 1694P1 16AAKP 14408-13 E-Z PACK QUEEN OF THE VALLEY 380655169865 H5301ALCON1CPAK10 Lot Number: 16J3V0 14533-18 OPHTHALMIC UOFL HOSPITAL 380655128893 H5301ALCON1CPAK10 Lot Numbers: 15TDRD JZ5187567 162V0V JZ5188305 1646L8 166KRH 167F66 1689PX JZ5196723 169Y7X JZ5196725 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 380655119266 H5301ALCON1CPAK10 Lot Numbers: JZ5182015 JZ5179828 JZ5182017 JZ5182019 JZ5182021 JZ5182023 JZ5182025 JZ5189545 JZ5189547 1683UH JZ5193687 JZ5193689 JZ5193693 JZ5193691 JZ5193695 JZ5194353 JZ5194347 JZ5194349 169624 169J38 16EJNU 16EK31 16EK3F 16ERDT 16F1Y8 16F5KY 16F5L7 16FU6F 16H79A 16HE8M 16HHPC 16HLN4 16KNX3 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 380651669154 H5301ALCON1CPAK10 Lot Numbers: 15URRF 15VH42 15X4TK 163KMN 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 380651696761 H5301ALCON1CPAK10 Lot Numbers: JZ5181119 JZ5181117 JZ5196980 16CTW0 JZ5198018 JZ5202443 16J9TD 16KP1U 15502-10 DR NEWCOMB LEXINGTON CLINIC 380651659216 H5301ALCON1CPAK10 Lot Numbers: 15VWRR 15YTL6 16354H 164NVE 168F5L 169J44 16AKCV 16CWXJ 16DJ2K 16H03D 16JEP1 16KFCX 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 380651662247 H5301ALCON1CPAK10 Lot Numbers: 166XP7 16C3UV 16DJ3V 16KWHA 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 380651661172 H5301ALCON1CPAK10 Lot Numbers: 160H15 16KWHD 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 380655147849 H5302ALCON2CPAK20 Lot Numbers: 15Y1VM 161CWF 1644WE 1673RU 1689LK 16A4WT 16C9X6 16J2F2 16001-12 DR YONKER/BESCAK CESC 380655139660 H5301ALCON1CPAK10 Lot Numbers: JZ5180191 JZ5181344 15VAHL 16096T 16273U 164VL5 16734V 167W3J 169A11 16EE2H 16001-13 DR YONKER/BESCAK CESC 380655171158 H5302ALCON2CPAK20 Lot Numbers: 16J2HU 16KA4P 16013-12 DR MCDONALD NORTH FL SURG PAVILION 380651674004 H5301ALCON1CPAK10 Lot Numbers: 161MY7 162223 JZ5187506 1689M3 169AEM 16AKEA JZ5196677 JZ5197622 JZ5200898 16FC7P JZ5202375 JZ5203185 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 380651661769 H5301ALCON1CPAK10 Lot Numbers: 15V1HL 166DNC 169159 16177-08 OPHTHALMIC DENVER EYE SURG CTR 380655157817 H5301ALCON1CPAK10 Lot Numbers: 15UW01 15V1CJ 1612U0 161TEL 162WJC 163538 163RCP 16511H 1655CY 1655E2 167ATY 1688PU JZ5193937 JZ5193933 JZ5193931 JZ5193935 JZ5201037 JZ5198450 JZ5201039 16F3D5 JZ5204193 JZ5204191 16J854 16JKM5 16JLM8 JZ5203397 JZ5203395 JZ5203399 JZ5205000 16K87P 16204-13 CATARACT V A HOSPITAL 380651672123 H5301ALCON1CPAK10 Lot Numbers: 15UTMT 15XHV5 160KD6 161PLJ 164EDC 167VJE 1699HP 169UNA 16AYJ6 16E0H7 16F5LV 16KTC2 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 380651700826 H5301ALCON1CPAK10 Lot Numbers: 15V674 160WNH 16AUW2 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 380655147382 H5301ALCON1CPAK10 Lot Numbers: 15VEPP 168LC6 168LCX 16E2RV 16J2FC 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 380655126097 H5301ALCON1CPAK10 Lot Numbers: JZ5183821 JZ5187052 JZ5199244 16EV7V 16J889 JZ5204459 JZ5204684 JZ5204457 JZ5205136 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 380651659971 H5301ALCON1CPAK10 Lot Numbers: JZ5180177 JZ5182256 164CKH 166MYH 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 380655164778 H5301ALCON1CPAK10 Lot Numbers: JZ5194680 16ARFT JZ5196164 16DTA1 JZ5203259 16HCE3 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 380655119747 H5301ALCON1CPAK10 Lot Numbers: JZ5181173 JZ5181175 JZ5181171 JZ5188259 JZ5188257 JZ5190516 JZ5190514 JZ5198210 JZ5200926 JZ5200924 16KA5L 16KEKE 16820-06 PHACO LONE PEAK SURGERY CENTER 380651666511 H5301ALCON1CPAK10 Lot Numbers: 15W2VD 1610P2 163RCL 169NKH 16A4UE 16C6UR 16HMVA 16K6LP 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 380651661318 H5301ALCON1CPAK10 Lot Numbers: 15UYWE 15W8DE 15YCAD 15YLVE 160NP9 162WV4 164ET1 164TX4 1681F9 168CY5 168R6V 16A6ML 16ATXM 16D7WW 16DN79 16HFM8 16K1VF 16K1VK 17201-18 SILVERA VALLEY SURGERY CENTER 380655157657 H5301ALCON1CPAK10 Lot Numbers: 15WVAA 15XD82 167MVD 167W3U 169M2C 169T25 16DVKX 16KA59 16KJMF 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 380651696785 H5301ALCON1CPAK10 Lot Numbers: 15WPF0 160H1R 165YV6 1662C2 168PWA 16DTAJ 16DTC0 16EH2C 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 380655134528 H5301ALCON1CPAK10 Lot Numbers: 15UTNX 1673TC 168M3N 17361-08 MICRO PAK CARLE FOUNDATION HOSP 380651696747 H5301ALCON1CPAK10 Lot Numbers: 15VERA 15WTX3 1616K9 JZ5190118 16354N 163XWJ 163XWN 166A8C 166YH6 16852A 16852V 16855T JZ5193699 JZ5193701 JZ5194148 JZ5194150 JZ5200707 JZ5200705 16F01E JZ5201205 JZ5201203 16F5M6 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 380655158548 H5301ALCON1CPAK10 Lot Numbers: 15VT7J 164TY3 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 380655165027 H5301ALCON1CPAK10 Lot Number: 1696C9 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 380651676138 H5302ALCON2CPAK20 Lot Numbers: 15X991 16716N 16A2HX 16DN5K 16JLLW 17520-05 DR GROSS CHARLESTON SURGERY CTR 380651663381 H5301ALCON1CPAK10 Lot Number: JZ5187064 168CUU 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 380651678842 H5301ALCON1CPAK10 Lot Numbers: 15XLME 163KLN 163V3R 164A33 1688R1 169CK3 16D8W7 16F4MM 16HK3T 16KFDN 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 380651657601 H5301ALCON1CPAK10 Lot Numbers: 15X4RH 163KKT 1646TM 165HYC 168PY0 16A24N 16D8W4 16J6EV 16K6M0 17541-07 HAIDER DUPONT SURG CTR 380655160985 H5302ALCON2CPAK20 Lot Number: 15X18M 17541-08 HAIDER DUPONT SURG CTR 380655165645 H5302ALCON2CPAK20 Lot Numbers: 168F65 16A9K9 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 380655143353 H5301ALCON1CPAK10 Lot Numbers: 15W11A 160WNE 164353 1668VE 16A31E 16JNAR 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 380655146606 H5301ALCON1CPAK10 Lot Numbers: JZ5180562 15WWJC 15Y1V6 16097R 1637LD 163V32 163V4A JZ5189819 165AXT JZ5189817 1664HV 166YHH 167J8W 167TC5 167W31 168J09 JZ5194495 JZ5193813 JZ5193811 JZ5193809 JZ5194489 JZ5193807 JZ5194491 JZ5194493 1698JY 169E7C 169F6A JZ5195434 JZ5195428 JZ5195430 JZ5195432 JZ5201592 JZ5201590 JZ5202435 17653-06 DR HUNT CHARLESTON AREA MED CTR 380655142066 H5302ALCON2CPAK20 Lot Numbers: 15WUUN 160696 1633CH 1657EE 1690H7 16ATTW 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 380655147405 H5301ALCON1CPAK10 Lot Numbers: 15UX9J 15VH5J 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 380655161357 H5301ALCON1CPAK10 Lot Numbers: 15YTLM 164A37 1658XR 16807U 169RXX 169T05 16C3TP 16E2T4 16EU0Y 16K3LP 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 380655156728 H5301ALCON1CPAK10 Lot Number: 160WMV 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 380655163351 H5301ALCON1CPAK10 Lot Numbers: 1647N0 1682R7 168PXR 16AJ0E 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 380655169186 H5301ALCON1CPAK10 Lot Numbers: 16HHP3 16J85W 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 380655152034 H5301ALCON1CPAK10 Lot Numbers: 15V1CP 15XLNC 15YV2R 162LRX 164NV2 16851D 16ENDF 16K86D 16KMT4 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 380651698741 H5301ALCON1CPAK10 Lot Numbers: 15X103 15XHRA 160RTK 166DR8 166V71 16719A 1687PL 16A80D 16DXK2 16DY09 16EW7J 16KLK3 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 380651669178 H5301ALCON1CPAK10 Lot Numbers: 15VH7H 15VKL4 15WWJ1 15XHD6 167LLC 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 380655147856 H5301ALCON1CPAK10 Lot Numbers: 15UNTM 15WAXK 160HMD 1646TX 164TYF 166KN1 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 380651673502 H5301ALCON1CPAK10 Lot Numbers: 15VWPU 15Y1W5 160YK5 161HRH 164A4P 167UFD 168M2C 169E4N 169Y3X 16AH0R 16D7PF 16EMJ6 16HTJ0 16KLKX 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 380655118641 H5301ALCON1CPAK10 Lot Numbers: 15W2MK 15W46V 163YXV 165AX9 1687HH 169ACY 16C5FA 16CFV5 16E014 16HK94 16KET2 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 380651698956 H5301ALCON1CPAK10 Lot Numbers: 15UNTC 15VMU8 1603FR 161MXX 163RCJ 165830 167UJ3 168K5C 16C5KK 16DEPH 16E00D 16EW68 16JTXA 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 380655160596 H5301ALCON1CPAK10 Lot Numbers: 160CDC 163V3H 166N0T 16DXK0 16E002 167E55 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 380655169438 H5301ALCON1CPAK10 Lot Number: 16HLNK 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 380651691520 H5301ALCON1CPAK10 Lot Numbers: 15XD8P 15XHEP 160CD8 160KCX 1632XR JZ5188094 1646PR JZ5189592 JZ5190276 JZ5196577 JZ5197432 JZ5200319 JZ5201138 JZ5203349 JZ5205873 18401-04 MCGRAW SIGHTPATH MEDICAL 380655146927 H5301ALCON1CPAK10 Lot Numbers: 160XR6 162LUU 167T95 168XD1 16AKE4 16E0YF 16EFA9 16EH0N 16H048 16KEUR 18406-03 DR KUCHINKA HAYWARD AREA HOSP 380651686441 H5301ALCON1CPAK10 Lot Numbers: 1673TW 1673U4 167TAT 168EJP 168K52 16HPXM 16JLKT 18427-07 CATARACT V A HOSPITAL 380651699038 H5301ALCON1CPAK10 Lot Numbers: 15VP93 16406W 167MUN 167VJH 168K62 18427-08 CATARACT V A HOSPITAL 380655168370 H5301ALCON1CPAK10 Lot Numbers: 16DYYE 16F3F6 16J3TA 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 380651662506 H5301ALCON1CPAK10 Lot Numbers: 15V6U8 15WAN9 16591E 167E55 167XDC 1694T6 169YF2 16ACKW 16JA61 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 380655156568 H5301ALCON1CPAK10 Lot Numbers: 15V01H 15V01J 168LLX 18550-04 DR HU TORRES CAT & LSR CNTRL 380655151518 H5302ALCON2CPAK20 Lot Numbers: 1655ER 168K5N 16DJ3U 18555-04 DR WU - CENTURION CAT & LSR CNTRL 380655152751 H5302ALCON2CPAK20 Lot Numbers: 15WTXL 161HRN JZ5187444 JZ5188106 18636-10 CATARACT BONNER GENERAL HOSPITAL 380651688094 H5301ALCON1CPAK10 Lot Numbers: 15VH4U 15X0W9 160YLK 16336T 166DR4 16915J 16C250 16ERF0 16HFK2 18649-05 NEASC CATARACT NORTHEAST ALIANCE SURG 380655165393 H5301ALCON1CPAK10 Lot Numbers: 168XDY 16C5HN 18685-06 CATARACT PAK CHRISTUS SANTA ROSA ASC 380655154397 H5301ALCON1CPAK10 Lot Numbers: 15X59N 1610M1 162789 164XYP 16A4XJ 16D16V 16ELKD 16KKDA 18873-06 CENTURION PROUET LAFAYETTE SURGICAL SPEC 380655132166 H5301ALCON1CPAK10 Lot Numbers: 15VEP8 16DJ2F 16JCAK 18888-04 SMITH EYE SURGERY CENTER OF ELIZABET 380655160107 H5301ALCON1CPAK10 Lot Numbers: 15W84F 15Y3R1 164LKJ 1687PV 16AHPY 16EMDM 16KAAM 18889-01 PROCTOR EYE SURGERY CENTER OF ELIZABET 380651669529 H5301ALCON1CPAK10 Lot Numbers: 15Y6XR 1616LM 168AUJ 168AUM 168CTN 16CW7X 16EP34 18907-02 CATARACT THE EYE SURGERY CENTER 380655127407 H5301ALCON1CPAK10 Lot Numbers: 15W6ER 15W6U6 15YM22 1612VD 163KRK 163KRM 164MD1 164MED 16846H 16846R 1697FE 169M1X 16ARW4 16FUY5 16HDPC 16HE7U 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 380651691940 H5301ALCON1CPAK10 Lot Numbers: 167MRE 167X9F 16903L 16A801 16DJ28 16HLNN 16JEMY 18912-02 RHEE CATARACT THE ASC AT UNITED MEDICAL 380655138557 H5301ALCON1CPAK10 Lot Numbers: 15YN5T JZ5188135 JZ5188885 JZ5189375 16JNAL 16KKC4 18915-02 PETRIE PACK THE ASC AT UNITED MEDICAL PA 380651691964 H5301ALCON1CPAK10 Lot Numbers: 15W8EL 15YTLW 162WVP 168K5D 16A80F 16DL1E 16HK2N 16JCAD 18918-03 DR SIMMONS CENTER FOR AMB SURGERY 380655153147 H5301ALCON1CPAK10 Lot Numbers: JZ5181868 JZ5182649 JZ5184480 JZ5185579 161KHH JZ5188136 JZ5197201 16CW8A JZ5199160 JZ5203052 JZ5203702 16J2FX 18942-03 CENTURION PAK BAPTIST BEAUMONT SURG AFFI 380651692855 H5301ALCON1CPAK10 Lot Numbers: 15UUX9 15YTM3 1689JT 19050-03 DR CARTER GRAND VALLEY SURGICAL CENTER 380655139776 H5301ALCON1CPAK10 Lot Numbers: 15VCP0 15YTLT 162LVL 164TWE 168X60 16A24U 16AAMC 16CD88 16HMXR 16KMUY 19115-05 DR HUFFMAN AND WEST CUMBERLAND VALLEY SU 380655115169 H5301ALCON1CPAK10 Lot Numbers: 15WC64 160M20 163YYW 19184-05 DR KEIL PAK KEIL LASIK VISION CENTER 380655160725 H5301ALCON1CPAK10 Lot Numbers: 16717F 16851P 16JEMT 16KNXJ 19346-02 HUFFMAN/WEST LAKE CUMBERLAND 380655134474 H5301ALCON1CPAK10 Lot Numbers: 15VMPW 1612RR 1687PF 1687UY 16DPP1 16ERF4 16HXYR 16KKLK 19353-01 ECHOLS HAMILTON EYE INSTITUTE 380655135372 H5301ALCON1CPAK10 Lot Numbers: 15UWHY 15XLPE 165YRY 1693MF 16HMTL 16HV8R 16K87K 16KMPK 16KTD0 19407-06 CATARACT V A MEDICAL CENTER #637 380655147047 H5301ALCON1CPAK10 Lot Numbers: 160H5X 161WNR 19407-07 CATARACT V A MEDICAL CENTER #637 380655163467 H5301ALCON1CPAK10 Lot Numbers: 161KK8 164VKU 1654YX 168CXC 19408-02 MCMINNVILLE CATARACT MCMINNVILLE SURGERY 380655148679 H5301ALCON1CPAK10 Lot Numbers: 15WWJ2 15Y6XC 160RPC 161MX7 JZ5187463 JZ5187461 JZ5188168 JZ5189392 164LNT 16HDRJ 16HHP1 16KLJV 16KNXA 19409-06 LEXINGTON CATARACT LEXINGTON MED CTR 380655154588 H5301ALCON1CPAK10 Lot Numbers: 15XDA4 16198N 1682PR 168F5W 168XCP 16ANW8 16D7PY 16ENDP 16HLWX 16JWYT 19501-03 HAIDER EYE SURGERY CENTER OF ELIZABET 380655153673 H5302ALCON2CPAK20 Lot Number: 1603EE 19515-05 CHATTERJEE THE EYE SURGERY CENTER 380655160848 H5301ALCON1CPAK10 Lot Numbers: 160YNA 164VL9 1686E5 168LLY 16A84R 16H087 16HLX8 16KH4P 19533-02 DR COCO RUTLAND REG MED CTR 380655166130 H5301ALCON1CPAK10 Lot Numbers: 16AAMX 16K4TA 19554-02 DR NIESPODZANY BAY EYE SURGERY CENTER 380655161036 H5301ALCON1CPAK10 Lot Numbers: 15XVE1 164HH4 164NV8 16858C 16AAMP 16EK7M 16KEUD 19628-01 BASTOS KINGS DAUGHTERS HOSPITAL 380655159729 H5301ALCON1CPAK10 Lot Numbers: 15UXCE 162CNP 16F595 19677-01 CATARACT IOR ADVANCED LASER & CATARACT 380655163535 H5302ALCON2CPAK20 Lot Numbers: 161N3F 167ADJ 19729-01 DR DICKES OPHTHALMOLOGY LTD 380655166505 H5302ALCON2CPAK20 Lot Numbers: 1694RD 16ANV3 16CTV6 19729-05 DR DICKES OPHTHALMOLOGY LTD 380655169698 H5302ALCON2CPAK20 Lot Numbers: 16EH0E 16FF6H 16FJYY 16H2XX 19746-01 DR LEALE PAK LAWRENCE COUNTY SURGERY CTR 380655166666 H5301ALCON1CPAK10 Lot Numbers: 16A303 16A4W8 16AAL8 16EK2U 19770-01 DR. BADER CAT PAK SW LINCOLN SURGERY CEN 380655167595 H5301ALCON1CPAK10 Lot Number: 16A4XA 19787-01 DR BORDEWYK OPHTHALMOLOGY LTD 380655170281 H5302ALCON2CPAK20 Lot Number: 16H04F 19821-02 DR KROLL CLARKSVILLE EYE SURGERY CENTER 380655171066 H5301ALCON1CPAK10 Lot Numbers: 16F3K0 16J852 16K6K9 19830-01 HAIDER CCMH CORPORATION 380655172902 H5301ALCON1CPAK10 Lot Number: 16K2CD 3316-33 CATARACT V A MEDICAL CENTER 380655115497 H5301ALCON1CPAK10 Lot Numbers: 15V4RE 15WTV7 16444N 167LNM 16898C 16A551 16AKL6 3316-35 CATARACT V A MEDICAL CENTER 380655167830 H5301ALCON1CPAK10 Lot Numbers: 16ELTX 16K8RT 3434-49 CATARACT SKIFF MED CTR 380655159941 H5301ALCON1CPAK10 Lot Number: 15YJT9 3434-50 TURNER CATARACT SKIFF MED CTR 380655169490 H5301ALCON1CPAK10 Lot Number: 16EUWT 4331-32 CATARACT CATARACT 380653344967 H5301ALCON1CPAK10 Lot Numbers: 15WTTU 160NNC 166A9F 166YKF 1687FX 169FDU 16ECTK 16EUVM 16HTH9 16KFYD 16KP13 4520-22 OPHTHALMIC COLISEUM SAME DAY SURG 380653398960 H5301ALCON1CPAK10 Lot Numbers: JZ5179661 16KMX9 4937-35 CATARACT ASHTABULA MED CTR 380651698598 H5301ALCON1CPAK10 Lot Numbers: 15V51V 160VUX 162LT4 164PYX 166DRC 168CV1 168K55 169J47 16ACFK 16DC7Y 16HFHD 16JJ7M 5322-68 CATARACT SURGICENTER OF PALO ALTO 380655149300 H5301ALCON1CPAK10 Lot Numbers: 15UV37 15UWDT 15VUPD 15YE38 JZ5187250 JZ5187254 JZ5187252 JZ5187535 JZ5194773 JZ5187539 162V35 162Y5N JZ5194775 16A2JP 16AAM9 16D6WV JZ5198788 JZ5198790 16E2R2 16ECU8 16J2F9 JZ5203407 16JA9F 16KT7H 6274-17 ST ANTHONY CATARACT PACK ST ANTHONY HOSP 380655170168 H5301ALCON1CPAK10 Lot Number: 16HPYM 6839-25 RICHARDSON COL HOSP GEORGETOWN 380655120323 H5301ALCON1CPAK10 Lot Numbers: 15V679 16063E 16372L 164NV3 1677CD 16828X 169NJW 16AYLX 16DVKR 6839-26 RICHARDSON COL HOSP GEORGETOWN 380655170090 H5301ALCON1CPAK10 Lot Numbers: 16EMK2 16KD1L 8189-69 CATARACT INLAND EYE CLINIC 380653416602 H5301ALCON1CPAK10 Lot Numbers: 15VAKN 15WTTM 15Y57L 15YK9A 160LUK 161WHR 162V2M 163KTE 16438L 165MVL 165N6C 16678Y 167P6C 168DA3 JZ5193835 JZ5193833 JZ5193963 JZ5193965 JZ5195241 16D18R 16D192 JZ5199823 JZ5202171 JZ5202167 JZ5202169 16JJ7U JZ5205279 8722-34 PHACO EMORY CLINIC INC 380655138588 H5301ALCON1CPAK10 Lot Numbers: 160LXM JZ5186195 JZ5188228 JZ5188804 JZ5202209 JZ5203955 9385-44 DR CAMPAGNA S TX REGIONAL MED CTR 380651675681 H5301ALCON1CPAK10 Lot Numbers: JZ5184199 1611XY JZ5188421 1689P6 9385-47 CATARACT METHODIST HOSPITAL SOUTH 380655167755 H5302ALCON2CPAK20 Lot Numbers: 16DR44 16E3K8 16FCAF 16FU61 9931-69 OPHTHALMIC JONES MEM HOSP 380655122655 H5301ALCON1CPAK10 Lot Numbers: JZ5180065 JZ5180595 JZ5182223 JZ5187142 JZ5188249 JZ5189472 JZ5194262 16E1JL 16EJ4M 16H7CW 9931-70 OPHTHALMIC JONES MEM HOSP 380655168653 H5301ALCON1CPAK10 Lot Numbers: JZ5201780 JZ5202701 JZ5203662 AS0720-75 CDN-CATARACT PACK HIGH RIVER HOSPITAL 380655158968 No UDI - Foreign Pak Lot Numbers: 15Y51E 15Y6X6 15Y6XT 162RYH 16435M 164NVP 1682R2 168E4U 169T10 169TW8 16ARF3 16AVW3 16D7PU 16D9L1 16EP2L 16FU8A 16HCFM AS0720-76 CDN-CATARACT PACK HIGH RIVER HOSPITAL 380655172193 No UDI - Foreign Pak Lot Number: 16J57N AS10104-15 CDN-CATARACT CENTURION WHITEHORSE GH 380655142578 No UDI - Foreign Pak Lot Numbers: 15YCEA 160KCK 164LEC 16ALMT 16CWL1 16H49A AS12593-09 NZ-DR WILSON CATARACT TAIRAWHITI DISTRIC 380655166970 No UDI - Foreign Pak Lot Numbers: 16A7K0 16AW7E 16DVFL 16EXY2 AS13781-13 CDN-MSJ CATARACT CENTURION VHC 380651691124 No UDI - Foreign Pak Lot Numbers: 15V1CY 15V7D8 15V7WC 15Y512 15Y56Y 15YDLM 15YDLW 162LUD 1630VL 1630VM 1630WD 1630XN 163372 165MRL 165MT5 16629M 16629R 166KP4 168E4E 168EJ5 168EJU 168EK3 168F5Y 168R5V 16929W 1693LV 169VHH 169Y98 169Y9J 169YA2 169YV0 16A9JK 16A9LA 16AALH 16ATRW 16ATT7 16C93A 16CCHM 16DCCU 16DCFU 16DD1D 16DF38 AS13781-14 CDN-MSJ CATARACT CENTURION VHC 380655169407 No UDI - Foreign Pak Lot Numbers: 16FT7Y 16H5FE AS13781-15 CDN-MSJ CATARACT CENTURION VHC 380655172766 No UDI - Foreign Pak Lot Numbers: 16K3KU 16K3LT 16K3LU 16K3LW 16K3LV AS13783-04 CDN-MSJ CATARACT TIPLESS 380653174076 No UDI - Foreign Pak Lot Numbers: 15Y6YA 15YCE4 16372N 16435H 166V6X AS15524-09 CDN-CATARACT CENTURION ALCON PASQUA HOSP 380655130162 No UDI - Foreign Pak Lot Numbers: 15UNU7 15V7VW 15V7WE 15V8CR 15VKVX 15WDNN 15WDRF 160082 1612RF 1612T4 1612TJ 1612TK 16353L 16353W 1641VN 164LLW 164LR6 1677ET 167JWA 167MNV 167VXC 167VY6 168F54 168J0F 169Y50 169Y6N 16A0T4 16A9JY 16A9KT 16A9LC 16ALRL 16AVWF 16CYTA 16EE16 16EE1U 16EE3A 16EF2T 16EF3L 16EK3D 16F03V 16F03Y 16HV97 16HV9J 16JR1M 16K4UC 16K3M9 16KH3A 16KJN4 16KMP4 16KMP9 16KMR4 AS17055-06 CDN-CATARACT CENTURION WEYBURN GH 380655157091 No UDI - Foreign Pak Lot Numbers: 15X5AE 16009X 167T8W 16A30T 16CFJA 16CK1H 16EKWT 16FPJH AS17612-04 AUS-DR HARRISBERG PHACO PAK BONDI JUNCTI 380655137833 No UDI - Foreign Pak Lot Numbers: 15VHD9 15YCE7 162Y51 1689L2 16DU4M 16F3H5 16H1HX 16J9TX AS18319-05 CDN-COMBO RETINAL PACK COMBO VANCOUVER 380655164549 No UDI - Foreign Pak Lot Number: 16ELTN AS18842-02 CDN-MSJ CENTURION LMD VANCOUVER 380651692527 No UDI - Foreign Pak Lot Numbers: 15UYW2 15YCVE 15YE2F 162RYX 162T03 1630VV 164A31 164MFR 165MTP 1677CF 167F6M 168LC0 168LCW 1697HV 16A84M 16A85K 16AYJ8 16DC97 16DCFR 16ELJL 16FA76 16HHPL 16HMUL 16HPXT 16JWXM AS19775-01 NZ-SX N PLYMOUTH CATARACT SX NEW PLYMOUT 380655167700 No UDI - Foreign Pak Lot Numbers: 16AYK6 16AYKP 16KD03 AS5894-31 CDN-CATARACT CENTURION 2.4 MILLS MH 380655155684 No UDI - Foreign Pak Lot Numbers: 15YC61 1610MK 1610P9 164A4H 167MNT 16A6MM 16A9K0 16A9K4 16AKF8 16ARH0 16EF3A AS5966-23 CDN-CATARACT CENTURION DELTA HOSPITAL 380651700451 No UDI - Foreign Pak Lot Numbers: 15VJL8 161VPA 161WD2 164EPR 1657K1 1683V3 16ARHU 16CD8D 16E4C5 16FU83 AS5966-24 CDN-CATARACT CENTURION DELTA HOSPITAL 380655172230 No UDI - Foreign Pak Lot Number: 16JTXP QNS39257B DR DEROSE VALLEY EYE SURGICAL CTR Non Sterile H5301ALCON1CPAK10 Lot Number: 16JL5D QNS39259A AHDIEH/CHERFAS/PEET VALLEY EYE SURGICAL Non Sterile H5301ALCON1CPAK10 Lot Number: 16JL5E
Recalling Firm/
Manufacturer		 Alcon Research, LLC
9965 Buffalo Speedway
Houston TX 77054-1309
For Additional Information Contact Kristen Kellerhals
817-661-4047
Manufacturer Reason
for Recall		 Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 03/15/2024, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via FedEx overnight to inform customer that, specific lots of Alcon Custom Pak containing Oasis Medical 27G Chang Hydrodissection Cannulas. Alcon has received customer complaints for foreign material, occlusions and bent tips for these cannulas. We are asking that you remove and dispose of the included 27G Chang Hydrodissection Cannula upon opening your Custom Pak for its specific surgical case. Customer are to take the following actions: 1. See Table 1 for list of affected Alcon Custom Pak lots that were distributed to their facility. They may have received Custom Pak lots assembled prior to this Field Correction notification, and as a result, they may be receiving affected inventory in future shipments. Any affected Alcon Custom Pak in the future, will be identified by a sticker and reads, "URGENT FIELD CORRECTION Discard enclosed 27G Chang Hydrodissection Cannula" 2. Review their inventory of Alcon Custom Pak lots against the lots listed in Table 1. For affected lots in their current on-hand inventory, affix the provided stickers directly to the outside of their affected Custom Pak in a location most easily seen. NOTE: Alcon Custom Pak units are sterile and should not be opened prior to surgery. 3. Upon opening of the identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed 27G Chang Hydrodissection Cannula. 4. Use a separate sterile standalone hydrodissection cannula, either from their own inventory or those supplied by Alcon. For impacted products that will ship in the future, Alcon is planning to ship sterile stand-alone substitutions. Call Alcon Customer Service (1-800-862-5266) if help it needed in obtaining replacement sterile standalone hydrodissection cannulas. 5. Keep Table 1 for their records should they receive any affected Alcon Custom Pak lots in the near future. Questions/concerns, contact Alcon Customer Service at 1-800-862-5266.
Quantity in Commerce 57,352 cannulas
Distribution Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Australia, Canada, and New Zealand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES
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