Alcon Research, LTD.: Medical Device Recall in 2023 - (Recall #: Z-2408-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Infinity FMS Pak

Product Classification:

Class II

Date Initiated: June 28, 2023

Date Posted: August 23, 2023

Recall Number: Z-2408-2023

Event ID: 92698

Reason for Recall:

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

Status: Ongoing

Product Quantity: 51,054 units

Code Information:

Catalog No. 8065741085, 8065750280, 8065750281, 8065752086, 8065752087, 8065752090, 8065752093, 8065752094, 8065752095, 8065752096; Product Code 100003158, 100004405, 100055054, 100009758, 100009094, 100009370, 100009098, 100009099, 100009100, 100009101; UDI-DI: 380657410859, 380657502806, 380657502813, 380657520862, 380657520879, 380657520909, 380657520930, 380657520947, 380657520954, 380657520961; Lots 154532, 1571CW, 1571CX, 150374, 14WCPD, 150374, 151J41, 151J42, 152H82, 152W36, 1598PY, 1598R0, 159LH6, 1571D2, 1598RA, 14YLLD, 14YLLE, 150FF5, 150FF6, 151J5W, 1532WH, 153JT7, 155LTD, 1571DK, 1571DL, 1571DM, 1571DN, 1571DP, 1571DR, 1571DT, 1571DU, 15A6MW, 15A6MX, 15C330, 15C331, 15C333, 15C334, 15D42R, 15DH93, 15EL09, 154539, 156751, 156752, 156755, 156756, 14VCLK, 14VCLL, 14VCLM, 14XPL9, 14XPLA, 14Y62U, 14Y62V, 15037P, 15037R, 15037T, 150FEL, 150FEM, 150FEN, 150FEP, 150FER, 150FET, 150FEU, 150FEV, 150FEW, 150FFX, 1532XL, 1532XU, 1532Y0, 1532Y5, 1532YC, 1532YE, 153JT8, 153JT9, 153JTA, 153JTC, 155LTE, 155LTF, 155Y8L, 155Y8M, 156D81, 156D82, 156D83, 156D84, 156D85, 156D86, 15A6MY, 15A6N0, 15C335, 15C336, 15C337, 15C338, 15CJJC, 15CJJE, 15CJJJ, 15CJJK, 15D42Y, 15D430, 15D437, 15D438, 15D439, 15D43A, 15D43C, 15DH9A, 15DH9P, 15DH9R, 15DH9U, 15DH9X, 14YXXD, 15EMYW, 1571E4, 1571E9, 153JTK, 158M7M, 158M7N, 151VEY, 153JTL, 1571EA, 158M7R.

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.

Voluntary or Mandated:

Voluntary: Firm initiated