CONSTELLATION Surgical Procedure Pack
Received Jul 27, 2026 · Event occurred Apr 9, 2026
Report 1644019-2026-03996 · MDR key 50016598
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065751613
Lot number
17P8D8
Product problems
- Suction Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A non-healthcare professional reported that cutter suction was not working while cutting during vitrectomy surgery. The surgery was completed on the same day, after replacing the product with another one. There was no patient impact.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress. A supplemental MDR will be filed as necessary in accordance with 21 CFR 803.56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).