Phaco Standalone Tips recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

Phaco Standalone Tips

Recalling firm

Alcon Research, LTD.

Quantity

444,372 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.

Recall date

August 23, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)