MalfunctionLRO
CONSTELLATION Surgical Procedure Pack
Received Jul 28, 2026
Report 1644019-2026-04034 · MDR key 50050978
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065751617
Lot number
1707M4
Product problems
- Failure to Cut
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A physician reported that actuation failure of cutter occurred during vitrectomy surgery. The procedure was completed after replacing the product 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).