MalfunctionLRO
CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 23, 2026
Report 1644019-2026-03980 · MDR key 25907365
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752438
Lot number
17R89Y
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 PHYSICIAN REPORTED THAT THE PROBE FAILURE OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.