Centurion FMS Pak
This recall is currently active, issued August 16, 2023. It was issued by Alcon Research, Ltd..
- Company
- Alcon Research, Ltd.
- Recall Initiated
- June 28, 2023
- Posted
- August 16, 2023
- Recall Number
- Z-2407-2023
- Quantity
- 87,839 units
- Firm Location
- Sinking Spring, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
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 / Code Info
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, 14X6CD, 14YXH8, 14YXH9, 14YXHA, 14YXHC, 14YXHD, 14YXHE, 14YXHF, 151V89, 151V8A, 151V8C, 151V8D, 151V8E, 1540HJ, 1540HK, 1540HL, 1540HM, 1540HN, 1540HP, 1540HR, 1540HT, 1540HU, 1540HV, 1565NE, 1565NH, 1565NK, 1565NL, 1565NN, 1565NR, 1583W8, 1583W9, 1583WC, 159PNE, 159PNF, 159PNH, 15CRUV, 15CRUW, 15CRUX, 15CRUY, 15CRV0, 15ET1K, 15ET1L, 15ET1N, 15J0YX, 15J100, 15J101, 15J107, 15J108, 15J109, 15LTY8, 15LTYA, 14X6CE, 14X6CF, 14X6CH, 14X6CJ, 14X6CK, 14X6CL, 14X6CM, 14YXHJ, 14YXHK, 14YXHL, 14YXHM, 14YXHN, 14YXHP, 14YXHR, 14YXHT, 151V8F, 151V8H, 151V8J, 151V8K, 151V8L, 151V8M, 1540HW, 1540HX, 1540HY, 1540J0, 1540J1, 1540J2, 1540J3, 1540J4, 1565P7, 1565P9, 1565PA, 1565PD, 1565PF, 1565PH, 1565PK, 1565PL, 15840V, 15840W, 159PP0, 159PP1, 159PP2, 15CRV2, 15CRV4, 15CRV5, 15CRV6, 15CRV7, 15ET1R, 15ET1T, 15ET1U, 15ET1V, 15ET1W, 15ET1X, 15ET1Y, 15ET20, 15ET21, 15J10A, 15J10C, 15J10D, 15J10J, 15LTYJ, 15LTYK, 15LTYL, 15LTYM, 150HD4, 1539WH, 1565PT, 15AV8X, 15C9PX, 14XPCM, 14Y8AY, 14Y8C0, 14YXHV, 14YXHW, 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.
Root Cause
Process control
Action Taken
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.