MalfunctionLRO
CONSTELLATION Surgical Procedure Pack
Received Jul 27, 2026 · Event occurred Jul 13, 2026
Report 1644019-2026-04014 · MDR key 50033209
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000095
Lot number
18042E
Product problems
- Failure to Cut
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A physician reported that the vitrectomy probe could not be cut during vitrectomy surgery. The surgery was completed on 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).