Recall archive / FDA device enforcement

Phaco Standalone Tips — FDA record Z-2410-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Phaco Standalone Tips
Reason: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Classification: Class II
Recalling firm: Alcon Research, LTD.
Quantity: 444,372 units
Agency-reported status: Ongoing
Source record identifier: Z-2410-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 23, 2023
Recall initiation date: Jun 28, 2023
Center classification date: Aug 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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