CONSTELLATION Surgical Procedure Pack
Received Jul 28, 2026 · Event occurred Jul 7, 2026
Report 1644019-2026-04042 · MDR key 50051602
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752450
Lot number
17W6EC
Product problems
- Failure to Cut
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A physician reported that the cutter did not actuate during calibration for surgery. The procedure type was unknown. The procedure was completed on same day after replacing the product with another one. There was no patient contact.
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).