Alcon Research, LTD. recalls Phaco Standalone Tips

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Catalog No. 30KTS, 30RTS, 8065740806, 8065740837, 8065750261, 8065750263, 8065750264, 8065750852, 8065750853, 8065751176, 8065751177, 8065751178, 8065752065, 8065752066, 8065790020, 8065790022, 8065790023; Product Code 100000692, 100000691, 100002823, 100002787, 100058543, 100004407, 100004408, 100006953, 100006952, 100006224, 100006225, 100006226, 100009104, 100009105, 100000696, 100000698, 100000708; UDI-DI: 380657403042, 380657403028, 380657408061, 380657408375, 380657502615, 380657502639, 380657502646, 380657508525, 380657508532, 380657511761, 380657511778, 380657511785, 380657520657, 380657520664, 380657900206, 380657900220, 380657900237; Lots 152A2F, 14T8U8, 14V9D7, 14WN7D, 14WNFC, 14YJJD, 15118L, 15KCLD, 14DNN3, 14XP2V, 154DY2, 155L1M, 155LD1, 15EM4L, 15FU4D, 14HA12, 14LH5X, 14LHL4, 14N03H, 14N0A6, 14PLY2, 14PM6Y, 14T8UF, 14T95K, 14UL3F, 14UY8J, 14V94T, 14V9DD, 14YJ8N, 14YJJN, 15075D, 1511AL, 155LD3, 15AYD1, 15AYD3, 15AYD4, 14C5L1, 14V8YF, 1510VH, 153KHX, 15AYF7, 15AYF8, 15CP8C, 151133, 14N03U, 14N0A7, 14PLY1, 14PM6X, 14V9DM, 14YJ93, 14YJJP, 153KR5, 154E88, 15AYD6, 15AYD7, 14C5UK, 14V953, 14YJ94, 1507DP, 153K87, 15AYD8, 15DMRM, 14D015, 14D0J0, 14DYMF, 14HA15, 14LH5W, 14LHL3, 14N03D, 14N0A3, 14PLY0, 14PM6W, 14T8UE, 14T95J, 14UL3C, 14UY8F, 14V94R, 14V9DC, 14WN7N, 14WNFN, 14XNWP, 14XP3Y, 14YJ8D, 14YJJK, 15075M, 1507DM, 15112P, 1511AH, 152A2N, 152ADL, 153K86, 153KR1, 154DY0, 155L2E, 155LD0, 156H57, 15AY6P, 15AY70, 15AYE9, 15AYEA, 15AYEC, 15AYED, 15AYEE, 15AYEF, 15CP8J, 15CPAD, 154E87, 14H9TN, 14HE56, 14LH5U, 14LHL1, 14N03C, 14N0A2, 14PLXY, 14PM6V, 14T8UC, 14T8UD, 14T95F, 14UL39, 14UL3A, 14UY8D, 14UY8E, 14V94M, 14V94N, 14V94P, 14V9D8, 14V9D9, 14V9DA, 14WN7L, 14WN7M, 14WNFL, 14WNFM, 14XNWM, 14XNWN, 14XP3W, 14XP3X, 14YJ89, 14YJ8C, 14YJJH, 14YJJJ, 15075E, 15075F, 1507DK, 1507DL, 15112M, 15112N, 1511AE, 1511AF, 152A2L, 152A2M, 152ADJ, 152ADK, 153K84, 153K85, 153KPW, 154DXX, 154E85, 155L2C, 155L2D, 155LCX, 155LCY, 15AY6M, 15AY6X, 15AYDP, 15AYDR, 15AYDT, 15AYE0, 15AYE2, 15AYE3, 15AYE4, 15AYE5, 15AYE6, 15AYE7, 15AYE8, 15CP8F, 15CP8H, 15CPAA, 15EM3D, 14MV1X, 14MV1Y, 14MV20, 14N03V, 14N0A8, 14PLXX, 14PM6U, 14T8UA, 14T95E, 14WN7H, 14WNFH, 14XNWJ, 14XP3U, 14YJ86, 14YJJE, 15075P, 1507DR, 15112J, 1511AA, 152A2K, 152ADF, 153KPU, 154DXV, 154E83, 155L28, 156H54, 156H6X, 15AY6U, 15AY73, 15AYDA, 15AYDD, 15AYDE, 15AYDF, 15AYDJ, 15CPAJ, 15DN0K, 14C5KL, 14LH5T, 14LHL0, 14WN7J, 14WNFJ, 14XNWK, 14YJ88, 15112K, 1511AC, 1589D4, 15AY6V, 146X4J, 14C5UL, 14UL38, 14UY8C, 14WN7K, 14WNFK, 14XNWL, 14XP3V, 14YJJF, 15112L, 15AYDL, 15DMRP, 14HA16, 14LHD7, 14N03E, 14N0A4, 14PLRJ, 14PM2C, 14T8LX, 14T90K, 14UL3D, 14UY8H, 14V8YD, 14V96T, 14WN7P, 14WN7R, 14WNFP, 14WNFR, 14XNWH, 14XP3T, 14YJ8F, 14YJJL, 15075R, 1507DT, 15112R, 1511AJ, 152A2E, 152ADA, 153K12, 153KHV, 154DR1, 154E0U, 155L2H, 155L2J, 155L98, 156H58, 156H73, 156H88, 15AY6R, 15AY71, 15AYEM, 14PLRK, 14PM2D, 14T8LY, 14T90L, 14UKXE, 14UY4A, 14V8YE, 14V96U, 14WN7T, 14WNFT, 14XNWF, 14XP3R, 14YJ8M, 14YJJM, 15075N, 1507DN, 15112T, 1529WJ, 152A4P, 153K13, 153KHW, 154DR2, 154E0V, 15AYEU, 15AYEW, 15AYEX, 15AYEY, 15AYF0, 15AYF1, 15AYF2, 15AYF3, 15AYF4, 15AYF5, 15AYF6, 15EM34, 150752, 14LH5P, 14LHKX, 14T95D, 14WN7E, 14WNFE, 14XP4P, 150752, 1507DF, 15110P, 15118M, 152ADD, 153KPN, 154DXU, 154E82, 155LCU, 15AYCU, 15AYCV, 15AYCW, 15E58E, 146WR7, 146X46, 14D0HP, 14UL37, 14UY8A, 14WN7F, 14WNFF, 14XP4R, 1507DH, 15110R, 15118N, 152A2J, 152ADE, 15AYCY, 15DMVX, 15AYD0.