MalfunctionLRO
CENTURION Surgical Procedure Pak
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 1644019-2026-04107 · MDR key 50096844
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752200
Lot number
17NPKL
Product problems
- Incomplete or Inadequate Connection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A physician reported that error code (loose tip) was displayed during calibration. The surgery type, procedure completion details were unknown. There was no patient contact with the defective product.
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)