MalfunctionLRO
CONSTELLATION Surgical Procedure Pack
Received Jul 31, 2026 · Event occurred Jul 13, 2026
Report 1644019-2026-04108 · MDR key 50097186
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065753106
Lot number
17WJW8
Product problems
- Suction Problem
- Failure to Cut
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A customer reported that probe was blocked, there was no cutting and no aspiration during vitrectomy surgery. The surgery was completed after replacing with a new 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)