Z-2408-2023Class II

Infinity FMS Pak

Name: Z-2408-2023 Infinity FMS Pak
Creator: Alcon Research, LTD.
Published: 2023-06-28
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2023-06-28 / Open, Classified / root cause: manufacturing process

FDA source

Alcon Research, LTD. began a recall of Infinity FMS Pak on 2023-06-28. FDA classified it as Class II and gives the reason as "Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2408-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-28
Posted: 2023-08-16
Recalling firm: Alcon Laboratories
Product: Infinity FMS Pak
Product code: HQC Unit, Phacofragmentation
Reason for recall: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at [email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2408-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16
Z-2407-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16
Z-2408-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16
Z-2409-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16
Z-2410-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16
Z-2411-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-16

Product code HQC

K021566Class IIInfinitiAlcon Laboratories, Inc. / cleared 2002-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)