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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity FMS Pak

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  Class 2 Device Recall Infinity FMS Pak see related information
Date Initiated by Firm June 28, 2023
Date Posted August 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-2408-2023
Recall Event ID 92698
510(K)Number K021566  
Product Classification Unit, phacofragmentation - Product Code HQC
Product Infinity FMS Pak
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.
Recalling Firm/
Alcon Research, LTD.
714 Columbia Ave
Sinking Spring PA 19608-1405
Manufacturer Reason
for Recall
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
FDA Determined
Cause 2
Process control
Action Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at Market.Actions@alcon.com. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at msus.safety@alcon.com or by phone at 1-800-757-9780, Option 5.
Quantity in Commerce 51,054 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALCON LABORATORIES, INC.