Z-2410-2023 Class II Ongoing

Recalled by Alcon Research, LTD. — Sinking Spring, PA

Recall Details

Product Type
Devices
Report Date
August 23, 2023
Initiation Date
June 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
444,372 units

Product Description

Phaco Standalone Tips

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 Pattern

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.

Code Information

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.