Alcon Research, LTD.: Centurion FMS Pak

Recall number

Z-2407-2023

Recalling firm

Alcon Research, LTD.

Product

Centurion FMS Pak

Status

Open, Classified

Initiated

2023-06-28

Posted

2023-08-16

Terminated

not on file

Reason

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Root cause

Process control

Action

Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at Market.Actions@alcon.com. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at msus.safety@alcon.com or by phone at 1-800-757-9780, Option 5.

Quantity

87,839 units

Distribution

Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, French Guayana, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saint Martin, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, USA, USVI, Utd. Arab Emir., Uzbekistan, Vietnam, and Yemen.

Lot, serial or model codes

Catalog No. 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202, 8065752203, 8065752216, 8065752217, 8065752245, 8065752917, 8065752918, 8065753134, 8065753135, 8065753136, 8065753159; Product Code 100241014, 100241015, 100241019, 100241020, 100055107, 100055110, 100009955, 100009963, 100009964, 100009965, 100009960, 100009961, 100010766, 100056645, 100055945, 100207171, 100207170, 100208838, 100208338; UDI-DI: 380650001337, 380650001344, 380650001382, 380650001399, 380657521920, 380657521937, 380657522002, 380657522019, 380657522026, 380657522033, 380657522163, 380657522170, 380657522453, 380657529179, 380657529186, 380657531349, 380657531356, 380657531363, 380657531592; Lots 14WW1F, 14WW1H, 14WW1J, 14X6CN, 14X6CP, 14X6CR, 14X6CT, 14X6CU, 14X6CV, 14XPE9, 14XPEA, 14XPEC, 14XPED, 14XPEE, 14XPEF, 14XPEH, 14Y8C2, 14Y8C3, 14Y8C4, 14Y8C5, 14Y8C6, 14Y8C7, 14YLMF, 14YLMH, 14YLMJ, 14YLMK, 14YLML, 14YLMM, 14YLMN, 14YLMP, 14YXHY, 14YXJ0, 14YXJ1, 14YXJ3, 14YXJ4, 14YXJ5, 14YXJ6, 14YXJ7, 150HDA, 150HDC, 150HDD, 150HDE, 150HDF, 150HDH, 150HDJ, 150HDK, 150HDL, 150HDM, 150HDN, 150HDP, 150HDR, 151V90, 151V91, 151V92, 151V93, 151V94, 151V95, 151V96, 151V97, 152F5H, 152F5K, 152F5L, 152F5M, 152F5N, 152F5P, 152F5R, 152F5T, 152F5V, 152F5W, 152F5X, 1539WP, 1539WR, 1539WT, 1539WU, 1539WV, 1539WW, 1539WX, 1539WY, 1540J9, 1540JA, 1540JC, 1540JD, 1540JE, 1540JF, 1540JH, 1540JJ, 1547AV, 1547AW, 1547AX, 1547AY, 1547C0, 1547C1, 1547C2, 1547C3, 1547C4, 1547C5, 1547C6, 1547C7, 1547C8, 1547C9, 154YDE, 154YDF, 154YDH, 154YDJ, 154YDK, 154YDL, 154YDM, 154YDN, 154YDP, 154YDR, 155HJP, 155HJR, 155HJT, 155HJU, 155HJV, 155HJW, 1565PX, 1565PY, 1565R0, 1565R1, 1565R2, 1571HV, 1571HW, 1571HX, 1571HY, 1571J0, 1571J1, 1571J2, 1571J3, 1571J4, 1571J5, 1571J6, 157DN2, 157DN3, 157DTR, 157DTT, 157DTU, 157DTW, 157DU2, 157DU4, 157DU5, 157DU6, 157DU7, 157DU8, 157DU9, 158CXM, 158CXN, 158CXP, 158CXR, 158CXT, 158CXU, 158CXV, 158CXW, 158CXX, 158CXY, 158VLV, 158VLW, 158VLX, 158VLY, 158VM0, 158VM1, 158VM2, 158VM3, 1599H3, 1599H4, 1599H5, 1599H6, 1599H7, 1599H8, 1599HF, 1599HH, 1599HJ, 1599HK, 1599HL, 1599HM, 1599HN, 1599HP, 1599HT, 159PPH, 159PPJ, 159PPK, 159PPL, 159PPM, 159PPN, 159PPP, 159PPR, 159PPT, 159PPU, 159PPV, 159PPW, 159PPX, 159PPY, 159PR0, 159PR1, 15A8H0, 15A8H2, 15A8H3, 15A8H4, 15A8H5, 15A8H6, 15A8H7, 15A8H8, 15A8H9, 15A8HA, 15A8HC, 15A8HD, 15A8HE, 15A8HF, 15A8HH, 15A8HJ, 15AV8Y, 15AV90, 15AV91, 15AV92, 15AV93, 15AV94, 15C9UU, 15C9UV, 15C9UW, 15C9UX, 15C9UY, 15C9V0, 15CRV8, 15CRV9, 15CRVA, 15CRVC, 15CRVD, 15CRVE, 15CRVF, 15CRVH, 15CRVJ, 15CRVK, 15CRVL, 15CRVM, 15CRVN, 15CRVP, 15D86V, 15D86W, 15D86X, 15D86Y, 15D870, 15D871, 15DRRV, 15DRRW, 15DRRX, 15DRRY, 15DRT0, 15DRT1, 15DRT2, 15E7KD, 15E7KE, 15E7KF, 15E7KH, 15E7KJ, 15E7KK, 15ET22, 15ET23, 15ET24, 15ET25, 15ET26, 15ET27, 15F8J1, 15F8J3, 15F8J4, 15H004, 15H005, 15H006, 15H007, 15H008, 15HK4E, 15HK4F, 15HK4H, 15HK4J, 15HK4K, 15HK4L, 15HK4M, 15J10N, 15J10V, 15J116, 15JPYK, 15JPYL, 15JPYM, 15JPYP, 15JPYR, 15JPYT, 15KYKE, 15KYKH, 15LTWU, 15LTX0, 15LTX1, 15M91N, 15M91Y, 15M923, 15M928, 15METN, 15METP, 15PX3M, 14WW1L, 14WW1M, 14WW1R, 14WW1T, 14X6CY, 14X6D0, 14X6D2, 14X6D3, 14X6D4, 14X6D5, 14X6D6, 14XPEJ, 14XPEK, 14XPEL, 14XPEM, 14XPEN, 14XPEP, 14XPER, 14XPET, 14XPEU, 14Y8CA, 14Y8CC, 14Y8CE, 14Y8CF, 14Y8CH, 14Y8CK, 14Y8CL, 14YLMT, 14YLMU, 14YLMV, 14YLMW, 14YLMX, 14YLMY, 14YLN0, 14YLN1, 14YLN2, 14YLN3, 14YXJ8, 14YXJ9, 14YXJA, 14YXJC, 14YXJD, 14YXJE, 14YXJF, 14YXJH, 14YXJJ, 14YXJK, 14YXJL, 150HDV, 150HDW, 150HDX, 150HDY, 150HE0, 150HE1, 150HE2, 150HE3, 150HE4, 150HE6, 151VAD, 151VAE, 151VAF, 151VAH, 151VAJ, 151VAK, 151VAL, 152F60, 152F61, 152F62, 152F63, 152F64, 152F65, 152F66, 1539X0, 1539X1, 1539X2, 1539X3, 1539X4, 1539X5, 1539X6, 1539X7, 1540JN, 1540JP, 1540JR, 1540JT, 1540JV, 1540JW, 1540JX, 1540JY, 1547CF, 1547CH, 1547CJ, 1547CK, 1547CL, 1547CM, 1547CN, 1547CP, 154YDT, 154YDU, 155HJY, 155HK0, 155HK1, 155HK2, 155HK3, 1565R6, 1565R7, 1565R8, 1565R9, 1571JA, 1571JC, 1571JD, 1571JE, 1571JF, 1571JH, 1571JJ, 1571JK, 1571JL, 1571JN, 1571JP, 157DWT, 157DWV, 157DWX, 157DWY, 157DX1, 157DX3, 157DX5, 157DX7, 157DX9, 157DXC, 157DXE, 158CY0, 158CY1, 158CY2, 158CY3, 158CY4, 158CY5, 158CY6, 158CY7, 158CY8, 158CY9, 158CYA, 158VM4, 158VM5, 158VM6, 158VM7, 158VM8, 158VM9, 158VMA, 158VMC, 1599JL, 1599JM, 1599JN, 1599JP, 1599JT, 1599JU, 1599LK, 1599LL, 1599LM, 1599LN, 1599LP, 1599LR, 1599LT, 1599LU, 1599LV, 1599LW, 159PR5, 159PR6, 159PR7, 159PR8, 159PR9, 159PRA, 159PRC, 159PRD, 159PRE, 159PRF, 159PRH, 159PRJ, 159PRK, 159PRL, 159PRM, 159PRN, 15A8HM, 15A8HN, 15A8HP, 15A8HR, 15A8HT, 15A8HU, 15A8HV, 15A8HW, 15A8HX, 15A8HY, 15A8J0, 15A8J1, 15A8J2, 15A8J3, 15A8J4, 15A8J5, 15AV97, 15AV98, 15AV99, 15AV9A, 15C9V2, 15C9V3, 15C9V4, 15C9V5, 15CRWF, 15CRWH, 15CRWJ, 15CRWK, 15CRWL, 15CRWM, 15CRWN, 15CRWP, 15CRWR, 15CRWT, 15D87D, 15D87E, 15D87F, 15D87H, 15F8J5, 15F8JA, 15F8JM, 15F8JU, 15F8JV, 15H009, 15H00A, 15H00C, 15H00D, 15H00E, 15HK4N, 15HK4P, 15HK4R, 15HK4T, 15HK4U, 15HK4V, 15HK4W, 15HK4X, 15J12H, 15J12L, 15J12P, 15J12V, 15J130, 15J134, 15J135, 15J136, 15JR05, 15JR06, 15JR07, 15JR08, 15JR09, 15JR0A, 15JR0C, 15JR0D, 15KYKN, 15KYKP, 15KYKR, 15KYKT, 15LU00, 15LU01, 15M92C, 15M92D, 15M92E, 15M92H, 15M92J, 15M92K, 15M92L, 15M92M, 15METX, 15MEU0, 15MEU1, 14WW1V, 14WW1W, 14X6D7, 14X6D8, 14X6D9, 14X6DA, 14XPEW, 14XPEX, 14XPEY, 14XPF0, 14Y8CP, 14Y8CT, 14Y8CU, 14YLPR, 14YLPT, 14YLPU, 14YXJP, 14YXJR, 14YXJT, 14YXJU, 150HE9, 150HEA, 150HEC, 150HED, 150HEE, 151VC3, 151VC4, 151VC5, 151VC6, 151VC7, 151VC8, 152F6R, 1539XF, 1539XH, 1539XJ, 1540K0, 1540K1, 1540K2, 1547CW, 1547CY, 1547D0, 1547D1, 1547D2, 155HK5, 155HK6, 1565RC, 1565RD, 1565RE, 1565RF, 1565RH, 156X16, 156X17, 156X18, 156X1D, 1571JU, 1571JV, 1571JW, 157DY8, 157DYA, 158VMF, 158VMH, 158VMJ, 158VMK, 1599M2, 1599M3, 1599M4, 1599M5, 1599M6, 1599M7, 1599M8, 1599M9, 1599MA, 159PRP, 159PRR, 15A8J6, 15A8J7, 15A8J8, 15A8J9, 15A8JA, 15A8JC, 15A8JD, 15A8JE, 15D87W, 15D87X, 15D87Y, 15D880, 15DRTC, 15DRTD, 15E7KL, 15E7KM, 15E7KN, 15E7KP, 15E7KR, 15ET28, 15ET29, 15ET2A, 15ET2C, 15ET2D, 15ET2E, 15F8KN, 15F8KP, 15H01Y, 15H020, 15H021, 15KYL9, 15KYLA, 15KYLC, 15LU03, 15LU06, 15LU07, 15MEU9, 15MEUA, 15MEUD, 14X6DC, 14X6DE, 14XPF5, 14XPF7, 14XPF8, 14Y8E9, 14Y8EA, 14YLPX, 14YLPY, 14YLR0, 14YLR1, 150HEF, 150HEH, 150HEJ, 151VC9, 151VCA, 152F6U, 1539XK, 1540K3, 155HK7, 1565RJ, 1565RK, 1565RL, 1565RM, 1571JX, 1571JY, 157M7P, 158VML, 158VMM, 1599MC, 1599MD, 1599ME, 1599MF, 159PRT, 15A8JH, 15A8JJ, 15A8JL, 15A8JM, 15A8JN, 15A8JP, 15A8JR, 15A8JT, 15D883, 15D884, 15E7KW, 15E7KX, 15E7KY, 15E7L0, 15H022, 15KYLD, 15KYLE, 15MEUH, 15PWXF, 14XPAM, 14XPAN, 14XPAP, 150HA2, 150HA3, 151V6V, 151V6W, 152F44, 1539TX, 1539U0, 155HFY, 157LXH, 157LXJ, 158VL8, 159PMX, 159PMY, 15C9NH, 15D858, 15D859, 15DRPK, 15DRPL, 15DRPM, 15DRPN, 15F8CV, 15FYY0, 15KYJ4, 15LTVJ, 14Y8AK, 14Y8AL, 14YLLU, 150HAK, 150HAT, 151V6X, 151V6Y, 152F45, 1539XU, 1539XV, 1540H0, 155HHN, 155HHP, 1565JW, 1577YD, 157LXK, 157LXM, 157LXN, 158VL9, 159PN2, 159PN5, 15CRNT, 15CRNV, 15CRNY, 15CRP1, 15D85C, 15D85D, 15DRPR, 15ET09, 15F8D3, 15FYY4, 158419, 14WW0H, 14WW0J, 14WW0K, 14WW0P, 14WW0R, 14X6A9, 14X6AA, 14X6AC, 14X6AD, 14X6AE, 14XPAV, 14XPAW, 14XPAX, 14Y8AM, 14Y8AN, 14YLLV, 14YLLW, 14YXF2, 14YXF3, 14YXF4, 150HAV, 150HAW, 150HAX, 150HAY, 150HC0, 150HC1, 150HC2, 150HC3, 150HC4, 150HC5, 150HC6, 150HC7, 150HCH, 150HCJ, 150HCK, 150HCM, 151V70, 151V71, 151V72, 151V73, 151V74, 152F48, 152F49, 152F4A, 152F4C, 152F4D, 152F4E, 152F4F, 152F4J, 152F4L, 152F4N, 152F4P, 1539U2, 1539U3, 1539U4, 1539U5, 1539U6, 1539U7, 1539U8, 1539U9, 1539UA, 154YD5, 154YD6, 154YD7, 154YD8, 154YD9, 154YDA, 154YDC, 154YDD, 155HJ7, 155HJ8, 155HJ9, 155HJA, 155HJC, 1565KA, 1565KD, 1565KF, 1565KJ, 1565KL, 1565KM, 157LXR, 157LXT, 157LXU, 157LXV, 157LXX, 157LXY, 15840X, 15840Y, 158415, 158416, 158418, 158419, 1585WV, 1585WW, 1585WX, 1585WY, 1585X0, 1585X1, 158CV1, 158CV2, 158CV3, 158CV4, 158CV5, 158CV6, 158CV7, 158CV8, 158CV9, 158CVA, 158VLC, 158VLD, 158VLE, 15AV8J, 15AV8K, 15AV8L, 15AV8M, 15AV8P, 15C9NL, 15C9NM, 15C9NN, 15C9NP, 15C9NR, 15C9NT, 15C9NU, 15C9NV, 15CRPC, 15CRPE, 15CRPF, 15CRPV, 15CRPX, 15CRPY, 15CRR0, 15D85P, 15D85R, 15D85T, 15D85U, 15D85V, 15D85W, 15D85X, 15DRPT, 15DRPU, 15DRPV, 15DRPW, 15DRPX, 15DRPY, 15E7JU, 15E7JV, 15E7JW, 15E7JY, 15E7K0, 15E7K1, 15ET0A, 15ET0C, 15ET0D, 15ET0E, 15ET0F, 15ET0H, 15ET0J, 15F8D5, 15F8D6, 15F8D7, 15F8D9, 15FYY5, 15FYY6, 15FYY7, 15FYY8, 15FYY9, 15HK3Y, 15HK40, 15HK41, 15HK42, 15HK43, 15HK44, 15J0Y6, 15J0Y7, 15JPXU, 15JPXX, 15KYJ9, 15LTW5, 15LTWC, 14WW0V, 14WW0W, 14WW0X, 14WW17, 14XPAY, 14XPC0, 14XPC1, 14XPC2, 14XPC3, 14XPC4, 14XPC5, 14Y8AP, 14Y8AR, 14Y8AT, 14Y8AU, 14Y8AV, 14YLLX, 14YLLY, 14YLM0, 14YLM1, 14YLM2, 14YLM3, 14YLM4, 14YLM5, 14YXF5, 14YXF6, 14YXF7, 14YXF8, 14YXF9, 14YXFA, 14YXFC, 150HCN, 150HCP, 150HCR, 150HCT, 150HCU, 150HCV, 150HCW, 150HCX, 150HCY, 150HD0, 151V76, 151V77, 151V7D, 151V7E, 151V7F, 154YE4, 154YE5, 154YE6, 154YE7, 154YE8, 155HJE, 155HJF, 155HJH, 155HJJ, 155HJK, 1565L8, 1565L9, 1565LA, 1565LD, 1565LF, 1565LJ, 157M7L, 15841A, 15841C, 15841D, 15841E, 15841F, 15841H, 15841J, 15841K, 1585X3, 1585X4, 1585X5, 1585X6, 1585X8, 1585X9, 1585XD, 1585XE, 158CVD, 158CVE, 158CVF, 158CVH, 158CVJ, 158CVK, 158CVL, 158CVM, 158VLF, 158VLH, 158VLJ, 15AV8R, 15AV8T, 15AV8U, 15AV8V, 15C9P7, 15C9P8, 15C9P9, 15C9PA, 15CRT1, 15CRT6, 15CRT7, 15CRTE, 15CRTJ, 15CRTL, 15CRTN, 15D861, 15D862, 15D863, 15D864, 15D865, 15D866, 15D867, 15D868, 15D869, 15DRR3, 15DRR4, 15DRR5, 15DRR6, 15DRR7, 15DRR8, 15DRR9, 15DRRA, 15DRRR, 15E7K4, 15E7K5, 15E7K6, 15E7K7, 15E7K8, 15E7K9, 15E7KC, 15ET0K, 15ET0M, 15ET0N, 15ET0P, 15ET0R, 15ET0T, 15ET0U, 15F8HN, 15F8HT, 15F8HU, 15FYYU, 15FYYV, 15HK46, 15HK47, 15HK48, 15HK49, 15JPY1, 15JPY4, 15M91F, 15M91M, 14XPCJ, 14Y8AW, 14YLMC, 150HD2, 151V7H, 1539VE, 1540H6, 155HJL, 157LY0, 157LY1, 15CRTX, 15CRU0, 15DRRP, 15F8HV, 15KYJY, 14XPCK, 14Y8AX, 14YLMD, 14YLME, 150HD3, 151V7K, 1539VY, 1540HE, 157LY4, 159PN6, 15D86N, 15D86P, 15DRRT, 15F8HW, 15FYYY, 15H000, 14X6C6, 14X6C7, 14X6C8, 14X6C9, 14X6CA, 14X6CC, 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150HD5, 150HD6, 1539WJ, 1539WK, 1539WL, 1540J8, 155HJM, 1565PV, 1565PW, 157LY6, 158VLU, 15C9R5, 15D86R, 15D86T, 15F8HX, 15H001, 15H002, 15JPYC, 15JPYE, 14XPE8, 14Y8C1, 150HD7, 151V8W, 1539WM, 1539WN, 155HJN, 157LY8, 15F8HY, 1545JX, 1565JK, 1585WM, 1585WR, 15AV9F, 15D885, 15H023, 15H024, 1585WT, 151PR4.

510(k) numbers

["K121555"]

PMA numbers

not on file

Product code

HQC

Firm FEI

2523835

Firm city

Sinking Spring

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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