MalfunctionLRO
UNITY TOTAL PLUS COMBINED PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 23, 2026
Report 1644019-2026-03960 · MDR key 25903703
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065000484
Lot number
17VW87
Product problems
- Infusion or Flow Problem
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Insufficient Information
Narrative
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).
Description of Event or Problem
A NURSE REPORTED THAT INFUSION LINE WAS OBSTRUCTED AND ERROR CODE WAS DISPLAYED BEFORE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.