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Infinity FMS Pak recallZ-2408-2023 · Alcon Research, LTD. · initiated Jun 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Alcon Research, LTD. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2408-2023
Status
Open, Classified
Initiated by the company
Jun 28, 2023
Posted by the FDA
Aug 16, 2023
Recalling firm
Alcon Research, LTD.
Quantity
51,054 units
Product code
HQC
FDA submissions
K021566
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 description

Infinity FMS Pak

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

10 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92698).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page