CONSTELLATION Surgical Procedure Pack
Received Jul 28, 2026 · Event occurred Jul 3, 2026
Report 1644019-2026-04030 · MDR key 50050626
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000095
Lot number
17AVMV
Product problems
- Failure to Cut
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A nurse reported that vitrectomy probe could not cut, and it still failed to cut even after reducing the cutting speed or when changed to different probe with same lot during vitrectomy surgery. The surgery was successfully completed on same day by replacing it with new product. 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).