Food, drugs, devices › Alcon Research, LTD.
Device recall: Constellation Procedure Pak
FDA enforcement event 92698 is a device recall by Alcon Research, LTD. of Sinking Spring, PA, initiated 28 Jun 2023 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Alcon Research, LTD. has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alcon Research, LTD., Sinking Spring, PA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2406-2023 | Constellation Procedure Pak | 10,580 units | Class II | Ongoing | 23 Aug 2023 |
| Z-2407-2023 | Centurion FMS Pak | 87,839 units | Class II | Ongoing | 23 Aug 2023 |
| Z-2408-2023 | Infinity FMS Pak | 51,054 units | Class II | Ongoing | 23 Aug 2023 |
| Z-2409-2023 | Legion FMS Pak | 2,628 units | Class II | Ongoing | 23 Aug 2023 |
| Z-2410-2023 | Phaco Standalone Tips | 444,372 units | Class II | Ongoing | 23 Aug 2023 |
| Z-2411-2023 | Alcon Custom Pak | 1,682,351 units | Class II | Ongoing | 23 Aug 2023 |
Context
Other enforcement events for Alcon Research, LTD.
All 28 events for Alcon Research, LTD.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.