CLASS II ONGOING Device recall · Reported 23 Aug 2023 · FDA Enforcement Report

Phaco Standalone Tips recalled by Alcon Research

Alcon Research is recalling Phaco Standalone Tips, distributed nationwide in the US. The recall was initiated on 28 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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.

Quantity recalled444,372 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2410-2023
FDA event ID: 92698
Recalling firm: Alcon Research, Sinking Spring, PA
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jun 2023
FDA classified: 16 Aug 2023
Reported: 23 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

28 Jun 2023	Recall initiated by company
16 Aug 2023	Classified by FDA	+49 days
23 Aug 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Phaco Standalone Tips

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Phaco Standalone Tips recalled?

Yes. Alcon Research recalled Phaco Standalone Tips on 28 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2410-2023.

Why was it recalled?

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

Which lots 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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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