Open, Classified

Legion FMS Pak

FDA Recall Z-2409-2023 · Posted 2023-08-16

Recall StatusOpen, Classified

Product CodeHQC

Date Initiated2023-06-28

Product Quantity2,628 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191650LEGION SystemAlcon Research, LLC · 2019-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.