Summary
The FDA issued a Class II for Constellation Procedure Pak by Alcon Research, LTD.. Reason: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench..
Details
Source
Device Recall
External ID
Z-2406-2023
Action Date
2023-08-23
Status
Ongoing
Category
device
Product Description
Constellation Procedure Pak
Lot/Code Info: Catalog No. 8065750958; Product Code 100007216; UDI-DI: 380657509584; Lots 14XM2J, 14Y1H6, 150HYJ, 150HYK, 151R72, 152CH0, 15309X, 156HWN, 15A13R, 15A13T, 15CF2X, 15CF2Y, 15CF30, 15CJ47, 15CJ48, 15CWAM, 15CWAN, 15D649.
Quantity Affected: 10,580 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-28
Company
Sinking Spring, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alcon Research, LTD. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research, LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research, LTD. have FDA actions?
Alcon Research, LTD. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2406-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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