MalfunctionLRO
CONSTELLATION SURGICAL PROCEDURE PACK
Received Jul 22, 2026 · Event occurred Jun 1, 2026
Report 1644019-2026-03944 · MDR key 25901696
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Alcon Research, Llc - HoustonModel number
NACatalog number
8065752451
Lot number
17NYJV
Product problems
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A NURSE REPORTED THAT LASER PROBE STOPPED WORKING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE LASER PROBE. 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).